bioMerieux, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1107-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

Product Classification:

Class II

Date Initiated: December 10, 2019

Date Posted: February 19, 2020

Recall Number: Z-1107-2020

Event ID: 84439

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.

Status: Terminated

Product Quantity: 1,218 US units total (726 US, 492 OUS)

Code Information:

US Model 30217-01 Lot 1007410330 and 1007393380

Distribution Pattern:

Distributed nationwide and 9 units to Biomerieux Canada.

Voluntary or Mandated:

Voluntary: Firm initiated