Device product
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Z-0742-2022
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 89568
- Status
- Terminated
- Classification
- Class II
- Quantity
- 480 kits
- Official record key
device-enforcement:Z-0742-2022
Official wording
Reason: Invalid calibrations (out of range high) while using the product.
Code information: Lot numbers 1008873260, exp. 01JUN2022.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Invalid calibrations (out of range high) while using the product.