CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cata
FDA device recall Z-1286-2023 · posted 2024-09-30 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories
- Reason for recall
- The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
- Action taken
- Randox UK (manufacturer) extended Urgent Medical Device Removal letter to the US distributor via email on 2/1/23. The distributor contacted the customer via email on 2/6/23. Letter states reason for recall, health risk and action to take: " Discontinue use of and discard any of the above immediately. Provide Randox with photographic evidence of the destruction of the kits. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " 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
- DCK
- Quantity affected
- 2 kits
- Distribution
- PA, OH, WV
- Date initiated
- 2023-02-01
- Date posted
- 2024-09-30
- Location
- Kearneysville, WV
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR (K953212) | Randox Laboratories, Ltd. | 1995-07-31 |