Recall Z-1286-2023
Randox Laboratories · initiated February 1, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Codes / lots: GTIN: 05055273201765 Batch: 588434
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
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1286-2023
- Initiated
- February 1, 2023
- Posted by FDA
- September 30, 2024
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Quantity
- 2 kits
- Distribution
- PA, OH, WV
- Recalling firm
- Randox Laboratories, Kearneysville, WV