Device product
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Z-1107-2020
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 84439
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,218 US units total (726 US, 492 OUS)
- Official record key
device-enforcement:Z-1107-2020
Official wording
Reason: 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.
Code information: US Model 30217-01 Lot 1007410330 and 1007393380
Distribution pattern: Distributed nationwide and 9 units to Biomerieux Canada.
Derived failure modes
-
Unknown
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.