Recall archive / FDA device enforcement
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. — FDA record Z-0742-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
- Reason
- Invalid calibrations (out of range high) while using the product.
- Classification
- Class II
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 480 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0742-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot numbers 1008873260, exp. 01JUN2022. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 5, 2022
- Recall initiation date
- Feb 9, 2022
- Center classification date
- Mar 14, 2022
- Termination date
- Apr 1, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.