Recall archive / FDA device enforcement
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum C... — FDA record Z-1286-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Classification
- Class II
- Recalling firm
- Randox Laboratories
- Quantity
- 2 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1286-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: 05055273201765 Batch: 588434 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
PA, OH, WV
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Feb 1, 2023
- Center classification date
- Mar 24, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.