Device recall
Z-2515-2025: Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia…
FDA device recall · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2515-2025 |
|---|---|
| Recall event | 97106 |
| 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 |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K090847 |
| FEI number | 3002701146 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database