VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
FDA device recall Z-0742-2022 · posted 2022-03-14 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Invalid calibrations (out of range high) while using the product.
- Action taken
- The recalling firm issued letters dated 2/9/2022 via Fed Ex Express Priority Overnight delivery service to their U.S. consignees. The letter described the issue, the impact to the user, and the required actions. Those actions included instructing the consignee to stop using and destroy any stock of the recalled lot and to complete the Acknowledgement Form and return it via email or FAX. The quantity discarded was to be completed on the Acknowledgement Form.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LKQ
- Quantity affected
- 480 kits
- Distribution
- Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.
- Date initiated
- 2022-02-09
- Date posted
- 2022-03-14
- Date terminated
- 2026-04-01
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIDAS CMV IGM ASSAY (K933549) | Biomerieux Vitek, Inc. | 1994-08-02 |