Z-1017-2025 Class II Ongoing
FDA device recall Z-1017-2025 was initiated by Randox Laboratories, Limited on December 20, 2024 and is designated Class II. Reason for recall: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. The recall status is ongoing. Affected quantity: 15 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- December 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
Product Description
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Reason for Recall
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Distribution Pattern
US Nationwide distribution Including PR.
Code Information
UDI-DI: 05055273204421 All lots within expiry