FDA-Device2020-02-19Class II
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
bioMerieux, Inc.
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.
Sold states
Distributed nationwide and 9 units to Biomerieux Canada.
Affected count
1,218 US units total (726 US, 492 OUS)
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2020Don't want to check this manually?
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