Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA device recall Z-0753-2024 · posted 2024-01-18 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories Ltd.
- Reason for recall
- Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
- Action taken
- Randox issued Urgent Medical Device Correction letter on 11/20/23 to the distribution center within the USA. The US distributor contacted the customer direct via email. Letter states reason for recall, health risk and action to take: Review your calibrator inventory of this lot and assess your laboratories needs for reimbursement for discarded inventory. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form, 12187-QA to technical.services@randox.com within five working days. If you have any questions or concerns please contact Randox Technical Services.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JIX
- Quantity affected
- 108 kits
- Distribution
- US Nationwide including Puerto Rico.
- Date initiated
- 2023-11-20
- Date posted
- 2024-01-18
- Location
- Crumlin, North, Ireland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX CALIBRATION SERUM (K053153) | Randox Laboratories, Ltd. | 2006-01-13 |