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Terminated

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

FDA Recall Z-1107-2020 · Posted None

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeLFY
Date Initiated2019-12-10
Date Terminated2021-02-16
Product Quantity1,218 US units total (726 US, 492 OUS)

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.

Firm Action

Users are instructed via customer letter to stop using the VIDAS VZG batches 1007410330 and 1007393380 and destroy the remaining products.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Distributed nationwide and 9 units to Biomerieux Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923122VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMBiomerieux Vitek, Inc. · 1992-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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