BioMerieux SA: Medical Device Recall in 2018 - (Recall #: Z-2169-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.

Product Classification:

Class II

Date Initiated: March 23, 2018

Date Posted: June 20, 2018

Recall Number: Z-2169-2018

Event ID: 80111

Reason for Recall:

A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.

Status: Terminated

Product Quantity: 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS

Code Information:

VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420

Distribution Pattern:

International distribution.

Voluntary or Mandated:

Voluntary: Firm initiated