FDA-Device2022-10-05Class II
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
bioMerieux, Inc.
Hazard
Invalid calibrations (out of range high) while using the product.
Sold states
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.
Affected count
480 kits
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0742-2022Don't want to check this manually?
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