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U.S. Department of Health and Human Services

Class 2 Device Recall Platelia Toxo IgM

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 Class 2 Device Recall Platelia Toxo IgMsee related information
Date Initiated by FirmMay 30, 2025
Date PostedSeptember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2515-2025
Recall Event ID 97106
510(K)NumberK090847 
Product Classification Enzyme linked immunoabsorbent assay, toxoplasma gondii - Product Code LGD
ProductPlatelia 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.
Code Information Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
FEI Number 3002701146
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
14620 Ne North Woodinville Way
Woodinville WA 98072-8440
For Additional Information ContactAnna Gralinska-Schram
510-741-6643
Manufacturer Reason
for Recall		Due to a risk of false positive results that could lead to unnecessary medical treatment.
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce35 kits
DistributionU.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LGD
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