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HARDY DIAGNOSTICS · Model Z135 · UDI-DI 00819398027779
10
510(k) clearances
211
Adverse events
21
Recalls
27
Facilities
Description
Anaerobe Nitrate Reagent B, Cleve's Acid for nitrate reduction test, formulated especially for anaerobic bacteria Hardy Diagnostics Anaerobe Nitrate Reagents A, B, and C are recommended for use in determining the nitrate reduction reaction of anaerobic bacteria. This product is to be use with Nitrate Reagent A (Cat. no. Z134) and Nitrate Reagent C (Cat. no. Z73).
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 |
| 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 |
| 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 |
| 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 |
| 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 |
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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.