Recall Z-1286-2023 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Randox Laboratories
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
| Date | Sep 30, 2024 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 pa |
| Quantity | 2 kits |
| Distribution | PA, OH, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953212 | C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR Randox Laboratories, Ltd., Jul 31, 1995 |