Recall Z-1107-2020— bioMerieux, Inc.

Name: FDA recall Z-1107-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-10

Class II · Terminated

Class II FDA medical device recall by bioMerieux, Inc., initiated 2019-12-10, terminated 2021-02-16. It names one FDA 510(k) clearance: K923122. Product: VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit. 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..

Recalling firm: bioMerieux, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-10
Terminated: 2021-02-16
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K923122 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMBiomerieux Vitek, Inc.·cleared 1992-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.