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REMEL, INC. · Model 7116-70 · UDI-DI 00848838091834
1
510(k) clearances
874
Adverse events
6
Recalls
3
Facilities
Description
MYCO PZA KIT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-20 | Becton Dickinson & Co. | BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates. |
| 2024-07-18 | Becton Dickinson & Co. | May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. |
| 2010-08-31 | Becton Dickinson & Co. | In vitro diagnostic device components are mislabeled. |
| 2010-08-31 | Becton Dickinson & Co. | In vitro diagnostic device components are mislabeled. |
| 2010-08-31 | Becton Dickinson & Co. | In vitro diagnostic device components are mislabeled. |
| 2010-08-31 | Becton Dickinson & Co. | In vitro diagnostic device components are mislabeled. |
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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.