Home / Recalls / Medical Devices
bioMerieux, Inc. recalls VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Recalled October 5, 2022 · FDA recall Z-0742-2022 · bioMerieux
Hazard
Invalid calibrations (out of range high) while using the product. · FDA Class II
Units
480 kits
Sold at
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.
Description
Invalid calibrations (out of range high) while using the product.
Product
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →