Z-0742-2022 Class II Terminated
FDA device recall Z-0742-2022 was initiated by bioMerieux, Inc. on Feb 9, 2022 and is designated Class II. Reason for recall: Invalid calibrations (out of range high) while using the product. The recall status is terminated (terminated Apr 1, 2026). Affected quantity: 480 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- Feb 9, 2022
- Termination Date
- Apr 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0742-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026