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Recall Observatory FDA recall evidence

Device product

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

Z-1107-2020

December 10, 2019

Class II

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

    reason.no_named_rule · v1.0.0

    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.