Recall Z-2515-2025

Reason for recall

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

FDA-determined cause: Process control

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