fda
6 records
FDA Device Recall: EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurem
2021-02-17
Class II — Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
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FDA Recall: Phadia US Inc — Class II
20180124
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. | Product: Phadia 1000 Instrument, Article Number ...
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FDA Device Recall: ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Spe
2018-04-11
Class II — The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
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FDA Device Recall: Phadia 1000 Instrument, Article Number 12-3800-01.
2018-01-24
Class II — The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
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FDA Device Recall: EliA Sample Diluent, Article number, 83-1023-01
2017-03-08
Class II — Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the li...
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FDA Device Recall: PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test sys
2012-09-05
Class III — Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The...
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nppes
1 records
ny_corps
1 records
NY Corp: PHADIA US INC.
2005-03-29
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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