Home / Recalls / BioMerieux SA / Z-2169-2018

Z-2169-2018 Class II Terminated

Recalled by BioMerieux SA — Marcy L'Etoile, N/A

FDA device recall Z-2169-2018 was initiated by BioMerieux SA on Mar 23, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 23, 2020). Affected quantity: 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS.

Recall Details

Product Type: Devices
Report Date: Jun 20, 2018
Initiation Date: Mar 23, 2018
Termination Date: Jun 23, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS

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.

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.

Distribution Pattern

International distribution.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2169-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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