Device recall
Z-0624-2024: SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays…
FDA device recall · Class III · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-0624-2024 |
|---|---|
| Recall event | 93543 |
| Product | SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349 |
| Product code | OHQ |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 1000361607 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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