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bioMerieux, Inc. recalls VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Recalled February 19, 2020 · FDA recall Z-1107-2020 · bioMerieux
Hazard
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result. · FDA Class II
Units
1,218 US units total (726 US, 492 OUS)
Sold at
Distributed nationwide and 9 units to Biomerieux Canada.
Description
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
Product
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →