Calibration Serum Level 3 CAL2351
FDA device recall Z-0752-2024 · posted 2024-01-18 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories Ltd.
- Reason for recall
- CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
- Action taken
- Randox issued Urgent Medical Device Correction Letter via email to the US and PR Distributors on 11/20/23. Distributors contacted the customer directly. The Letter states reason for recall, health risk and action to take: Action to be taken: " Discuss the contents of this notice with your Medical Director if you have used the RX Series targets for CK Total in the aforementioned lots. " Complete and return the response form, 12187-QA to technical.services@randox.com within five working days. " Please discard all copies of the IFUs and download the latest versions from www.randox.com. 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
- 269 kits
- Distribution
- US Nationwide and Puerto Rico.
- Date initiated
- 2023-11-20
- Date posted
- 2024-01-18
- Location
- Crumlin, North, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX CALIBRATION SERUM (K053153) | Randox Laboratories, Ltd. | 2006-01-13 |