Home / Recalls / bioMerieux, Inc. / Z-1107-2020

Z-1107-2020 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
February 19, 2020
Initiation Date
December 10, 2019
Termination Date
February 16, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,218 US units total (726 US, 492 OUS)

Product Description

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

Reason for Recall

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.

Distribution Pattern

Distributed nationwide and 9 units to Biomerieux Canada.

Code Information

US Model 30217-01 Lot 1007410330 and 1007393380

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