Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog N
FDA device recall Z-1018-2025 · posted 2025-01-23 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories, Limited
- Reason for recall
- Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Action taken
- Randox Laboratories Ltd (manufacturer) extended recall to the distribution center in the USA via email on 12/20/24. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any copies of Roche Cobas c501 ISA listing nmol/1 claims. " Ensure clinical results are no longer reported in nmol/1 using the Roche Cobas c501 nmol/1 claims. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Randox Technical Services.
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- DFC
- Quantity affected
- 33 kits
- Distribution
- US Nationwide distribution Including PR.
- Date initiated
- 2024-12-20
- Date posted
- 2025-01-23
- Location
- Crumlin, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX LIPOPROTEIN (K011568) | Randox Laboratories, Ltd. | 2001-09-28 |