CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
- Company
- Randox Laboratories
- Recall Initiated
- February 1, 2023
- Posted
- September 30, 2024
- Recall Number
- Z-1286-2023
- Quantity
- 2 kits
- Firm Location
- Kearneysville, WV
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
Distribution
PA, OH, WV
Lot / Code Info
GTIN: 05055273201765 Batch: 588434
Root 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.