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Staphaurex Plus (450 test)
REMEL EUROPE LIMITED · Model R30950201 · UDI-DI 05056080501529
1
510(k) clearances
12
Adverse events
7
Recalls
8
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2011-12-21 | bioMerieux, Inc. | Reports of false negative results in organism identification. |
| 2010-01-15 | NERL Diagnostics Corporation | Unreactive Staph latex reagent |
| 2010-01-15 | NERL Diagnostics Corporation | Unreactive Staph latex reagent |
| 2009-07-20 | Remel, Inc | The products may give false positive results with some non-Staphylococcus aureus strains |
| 2009-07-20 | Remel, Inc | The products may give false positive results with some non-Staphylococcus aureus strains |
| 2008-10-07 | Remel, Inc | Control and test wells are reversed on some of the reaction cards. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.