Recall Z-2515-2025 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Bio-Rad Laboratories, Inc.
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.
| Date | Sep 4, 2025 (initiated May 30, 2025) |
| Status | Open, Classified |
| Reason | Due to a risk of false positive results that could lead to unnecessary medical treatment. |
| 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. . Re |
| Quantity | 35 kits |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090847 | PLATELIA TOXO IGM KIT MODEL 26211 Bio-Rad Laboratories, Jul 1, 2009 |