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Remel
REMEL, INC. · Model R8311007 · UDI-DI 00848838058233
10
510(k) clearances
169
Adverse events
6
Recalls
12
Facilities
Description
RapID YEAST PLUS System KT/20TST
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2021-12-20 | Biomerieux Inc | Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. |
| 2017-04-20 | Biomerieux Inc | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
| 2013-04-04 | Remel Inc | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed. |
| 2009-10-28 | Remel, Inc | There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. |
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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.