Z-0742-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- February 9, 2022
- Termination Date
- April 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 kits
Product Description
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Reason for Recall
Invalid calibrations (out of range high) while using the product.
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.
Code Information
Lot numbers 1008873260, exp. 01JUN2022.