Recall Z-0742-2022 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
bioMerieux, Inc.
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
| Date | Mar 14, 2022 (initiated Feb 9, 2022) |
| Status | Terminated |
| Reason | Invalid calibrations (out of range high) while using the product. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933549 | VIDAS CMV IGM ASSAY Biomerieux Vitek, Inc., Aug 2, 1994 |