Randox Laboratories, Limited: Device Recall
Recall #Z-1017-2025 · 12/20/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1017-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Randox Laboratories, Limited
- Status
- Ongoing
- Date Initiated
- 12/20/2024
- Location
- Crumlin, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
Reason for Recall
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Product Description
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Distribution Pattern
US Nationwide distribution Including PR.
Other Recalls by Randox Laboratories, Limited
- Class II: Risk 12/20/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.