FDA Enforcement
Class II
Ongoing
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Recall: Z-1286-2023
·
Reported April 5, 2023
Enforcement
- Recall Number
- Z-1286-2023
- Event ID
- 91745
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Randox Laboratories
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 5, 2023
- Initiation Date
- February 1, 2023
- Classification Date
- March 24, 2023
- Address
- 515 Industrial Blvd, N/A, Kearneysville, WV, 25430-2778, United States
Description
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
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
Code Info
GTIN: 05055273201765 Batch: 588434
Distribution
PA, OH, WV
Quantity
2 kits