Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-09-04Open, ClassifiedProcess control

  Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

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

• 2011-03-11TerminatedPMA

  Toxoplasma IgG ELISA kit ; Toxoplasma IgM ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

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

• 2010-03-05TerminatedLabeling False and Misleading

  Toxoplasma IgM ELISA 96 Well Kit, Catalog Number: TX055M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

  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.

• 2007-07-11TerminatedOther

  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.

• 2007-07-11TerminatedOther

  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.

• Open, ClassifiedNonconforming Material/Component

  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.

• TerminatedEnvironmental control

  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.

  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.