co_sos
1 records
fda
62 records
FDA Recall: Remel, Inc — Class II
20260422
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another an | Product: Yeastone Broth, 11ML, 10/BOX YY3462
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FDA Recall: Remel, Inc — Class II
20250806
The products may contain surface and subsurface contamination of Listeria monocytogenes. | Product: Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
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FDA Recall: Remel, Inc — Class II
20250226
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packag | Product: remel BLOOD AGAR EMB AGAR BIPLATE, REF...
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FDA Device Recall: Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
2025-08-06
Class II — The products may contain surface and subsurface contamination of Listeria monocytogenes.
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FDA Device Recall: Blood/MacConkey Biplate 100/PK, Product Number R02049
2025-08-06
Class II — The products may contain surface and subsurface contamination of Listeria monocytogenes.
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FDA Device Recall: Strep Selective II Agar, Product Number R01859
2025-08-06
Class II — The products may contain surface and subsurface contamination of Listeria monocytogenes.
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FDA Device Recall: Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TE
2025-06-18
Class II — Product may have an off color affecting perfomance
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FDA Device Recall: Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have b
2025-03-26
Class II — Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
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FDA Device Recall: remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic u
2025-02-26
Class II — Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the...
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FDA Device Recall: remel BactiDrop Acridine Orange, REF 21502, 50 per package.
2024-11-06
Class II — A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
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FDA Device Recall: Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemo
2023-07-05
Class II — The test medium may not perform as intended.
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FDA Device Recall: Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
2022-12-14
Class I — An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus sp...
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FDA Device Recall: Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
2022-12-14
Class I — An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus sp...
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FDA Device Recall: Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
2022-12-14
Class I — An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus sp...
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FDA Device Recall: Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
2022-12-14
Class I — An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus sp...
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FDA Device Recall: Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
2022-12-14
Class I — An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus sp...
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FDA Device Recall: Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
2022-12-14
Class I — An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus sp...
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FDA Device Recall: Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD for
2022-03-16
Class II — There are lower than expected MICs for some gram negative species.
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FDA Device Recall: ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the Un
2021-08-04
Class II — Out of Specification
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FDA Device Recall: Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Te
2021-04-21
Class II — When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
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FDA Device Recall: Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
2021-01-20
Class II — The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
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FDA Recall: Remel Inc — Class II
20190529
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration dat | Product: Thio Med w/Dex, Hem, Vit K (5ml) 100/P...
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FDA Device Recall: Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days...
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FDA Device Recall: Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in q
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 da...
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FDA Device Recall: Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in q
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 da...
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FDA Device Recall: Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 da...
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FDA Device Recall: Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days...
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FDA Device Recall: Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for us
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days...
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FDA Device Recall: Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use i
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 da...
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FDA Device Recall: Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qu
2019-05-29
Class II — Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 da...
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FDA Device Recall: remel THIOGLYCOLLATE MEDIUM, REF 05152
2018-09-19
Class II — Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
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FDA Recall: Remel Inc — Class II
20170315
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility t | Product: Remel, Haemophilus Test Medium (Agar) ...
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FDA Device Recall: Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Le
2017-05-03
Class II — Confirmed complaint of surface contamination of Listeria monocytogenes.
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FDA Device Recall: Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm pla
2017-03-15
Class II — Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
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FDA Device Recall: Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For th
2016-06-15
Class II — Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
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FDA Recall: Remel Inc — Class II
20151223
Antibiotic concentration may be insufficient which may result in incorrect test results. | Product: Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of
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FDA Device Recall: Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B
2015-12-23
Class II — Antibiotic concentration may be insufficient which may result in incorrect test results.
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FDA Device Recall: PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agg
2015-08-19
Class II — A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
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FDA Device Recall: PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bott
2015-08-19
Class II — A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
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FDA Device Recall: VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The Ver
2015-07-01
Class II — Use of the recalled product may result in false positive reports.
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FDA Device Recall: Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml
2015-03-11
Class II — Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
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FDA Recall: Remel Inc — Class II
20140430
A reagent contained within the product may return false negative results. | Product: Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of co
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FDA Recall: Remel Inc — Class II
20140129
Cartridges may contain individual discs which were not impregnated with antibiotic. | Product: Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges o
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FDA Device Recall: Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles,
2014-12-03
Class II — The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
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FDA Device Recall: Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box conta
2014-12-03
Class II — A reagent within the test may return false negative results.
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FDA Device Recall: Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pk
2014-11-19
Class II — Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
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FDA Device Recall: Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box cont
2014-04-30
Class II — A reagent contained within the product may return false negative results.
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FDA Device Recall: Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The
2014-04-30
Class II — A reagent contained within the product may return false negative results.
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FDA Device Recall: Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058
2014-03-26
Class II — Some of the discs may not be impregnated with the antibiotic.
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FDA Device Recall: Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, pack
2014-01-29
Class II — Cartridges may contain individual discs which were not impregnated with antibiotic.
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FDA Device Recall: Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, pac
2014-01-29
Class II — Cartridges may contain individual discs which were not impregnated with antibiotic.
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FDA Device Recall: Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg mer
2014-01-22
Class II — Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
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FDA Device Recall: Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal grou
2013-12-25
Class II — The product may give weak or false negative test results.
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FDA Device Recall: Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg,
2013-12-25
Class III — Boxes labeled as CIP5 may contain cartridges of AMP5.
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FDA Device Recall: remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml
2013-12-25
Class II — The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
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FDA Device Recall: Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT003
2013-09-04
Class III — Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
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FDA Device Recall: Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, e
2013-08-21
Class III — Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
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FDA Device Recall: The product is a lyophilized growth supplement for use with dehydrated culture m
2013-02-20
Class II — The product may contain low level microbial contamination which could result in incorrect results.
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FDA Device Recall: Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxi
2013-02-20
Class II — The firm is recalling the products due to a potential for false negative test results.
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FDA Device Recall: Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxi
2013-02-20
Class II — The firm is recalling the products due to a potential for false negative test results.
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FDA Device Recall: Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged w
2013-02-20
Class II — The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
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FDA Device Recall: Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264
2013-02-13
Class II — The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notifi...
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OSHA
1 records
OSHA Inspection (Complaint) - Remel Inc
2000-03-02
OSHA inspection at Remel Inc, ST PAUL, MN. NAICS: 000000. SIC: 4226
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