bioMerieux, Inc. recalls VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

Recall date

December 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1107-2020

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

Distributed nationwide and 9 units to Biomerieux Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit