CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report

Platelia Toxo IgM recalled by Bio-Rad Laboratories

Bio-Rad Laboratories is recalling Platelia Toxo IgM, distributed nationwide in the US. The recall was initiated on 30 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054

Quantity recalled35 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2515-2025
FDA event ID: 97106
Recalling firm: Bio-Rad Laboratories, Woodinville, WA
Classification: Class II
Status: Ongoing
Recall initiated: 30 May 2025
FDA classified: 4 Sep 2025
Reported: 10 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

30 May 2025	Recall initiated by company
4 Sep 2025	Classified by FDA	+97 days
10 Sep 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.

Nationwide California Colorado Florida North Carolina Nevada

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054

Where was it sold?

U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Bio-Rad Laboratories

All 27

Reported	Class	Recall	Company	Reason	Where
3 Apr 2024Device	CLASS II	Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled	Bio-Rad Laboratories	Other	Nationwide
17 May 2023Device	CLASS II	BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack recalled	Bio-Rad Laboratories	Packaging Defects	Nationwide
19 Apr 2023Device	CLASS II	BioPlex 2200, Anti-CCP Reagent Pack recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
19 Apr 2023Device	CLASS II	BioPlex 2200, Anti-CCP Calibrator Set recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
7 Dec 2022Device	CLASS II	CMV IgM EIA, in vitro diagnostic recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	14 states

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