Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immun

FDA device recall Z-2515-2025 · posted 2025-09-04 · Open, Classified

Recall details

Recalling firm

Bio-Rad Laboratories, Inc.

Reason for recall

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

Action taken

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 TechSupportUSSD-Redmond@Bio-Rad.com

Root cause

Process control

Status

Open, Classified

Product code

LGD

Quantity affected

35 kits

Distribution

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

Date initiated

2025-05-30

Date posted

2025-09-04

Location

Woodinville, WA

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