Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Platelia Toxo IgM Catalog Number 26211

Due to a risk of false positive results that could lead to unnecessary medical treatment.

Toxoplasma IgG ELISA kit ;

Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

Toxoplasma IgM ELISA 96 Well Kit, Catalog Number: TX055M

The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.

AxSYM Toxo IgG Reagent Pack; list 03B22; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

AxSYM Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

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 s

A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux 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.