VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the
FDA device recall Z-2331-2018 · posted 2018-06-29 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- Reason for recall
- Invalid calibration with low calibrator S1 while using the product.
- Action taken
- The recalling firm issued letters to the end users dated April 2018, via FedEx 2 Day Express explaining the issue, potential risk to health, and requested the impacted lots be destroyed. For further questions, please call (314) 731-8805.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CGJ
- Quantity affected
- 59 units distributed to the U.S.
- Distribution
- Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
- Date initiated
- 2018-04-09
- Date posted
- 2018-06-29
- Date terminated
- 2025-12-02
- Location
- Marcy L'Etoile, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921746) | Biomerieux Vitek, Inc. | 1992-06-16 |