Recalls / —
—#191956
Product
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
- FDA product code
- LKQ — Antibody Igm,If, Cytomegalovirus Virus
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K933549
- Affected lot / code info
- Lot numbers 1008873260, exp. 01JUN2022.
Why it was recalled
Invalid calibrations (out of range high) while using the product.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- bioMerieux, Inc.
- Address
- 100 Rodolphe St, Durham, North Carolina 27712-9402
Distribution
- 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.
Timeline
- Recall initiated
- 2022-02-09
- Posted by FDA
- 2022-03-14
- Terminated
- 2026-04-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #191956. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.