Z-2515-2025Class II

Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a...

Name: Z-2515-2025 Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a...
Creator: Bio-Rad Laboratories, Inc.
Published: 2025-05-30
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2025-05-30 / Open, Classified / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the... on 2025-05-30. FDA classified it as Class II and gives the reason as "Due to a risk of false positive results that could lead to unnecessary medical treatment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2515-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-30
Posted: 2025-09-04
Recalling firm: Bio-Rad Laboratories Inc.
Product: 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.
Product code: LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Reason for recall: Due to a risk of false positive results that could lead to unnecessary medical treatment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 05/30/2025, the firm sent via email an "URGENT MEDICAL DEVICE NOTIFICATION" to customers informing them that, as a result of an internal investigation, it was revealed that samples taken from a frozen negative control panel tested unexpectedly interpreted as equivocal or positive results. Customer are instructed to: . As the issue can alter product performance of the affected lots by reducing specificity and increasing the number of equivocal results, interpret positive results with caution and contact Bio-Rad Technical Support if you observe an unusual rate of false positive results. . Refer to the test limitations, as outlined in Section 9 Limitations of the Procedure, of the IFU 0002043 version 2023/11: Diagnosis of recent infection by T. gondii can only be established on the basis of a combination of clinical and serological data. The result of a single serum sample does not constitute sufficient proof for diagnosis of recent infection . . As noted in Section 8 Interpretation of Results, positive IgM results should be followed by confirmatory steps in accordance with CDC guidelines before initiating or continuing treatment. For questions or assistance, contact Bio-Rad Technical Support at 1-800-224-6723 or by email at [email protected]
Quantity in commerce: 35 kits
Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Product codes and lots: Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2515-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2515-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-04

Product code LGD

K090847Class IIPlatelia Toxo Igm Kit Model 26211Bio-Rad Laboratories / cleared 2009-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)