Z-1286-2023 Class II Ongoing
FDA device recall Z-1286-2023 was initiated by Randox Laboratories on February 1, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 2 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 kits
Product Description
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
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 Pattern
PA, OH, WV
Code Information
GTIN: 05055273201765 Batch: 588434