VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
- Company
- Biomerieux, Inc.
- Recall Initiated
- February 9, 2022
- Posted
- March 14, 2022
- Recall Number
- Z-0742-2022
- Quantity
- 480 kits
- Firm Location
- Durham, NC
Reason for Recall
Invalid calibrations (out of range high) while using the product.
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.
Lot / Code Info
Lot numbers 1008873260, exp. 01JUN2022.
Root Cause
Nonconforming Material/Component
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.