CRP Immunoturbidimetric reagent — Class II medical device recall Z-1286-2023
Ongoing recall by Randox Laboratories, reported 2023-04-05, distributed in OH, PA, WV. The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality
| Recall number | Z-1286-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Kearneysville, WV, United States |
| Recall initiated | 2023-02-01 |
| Classified | 2023-03-24 |
| Reported by FDA | 2023-04-05 |
| Distributed | OH, PA, WV |
| Quantity | 2 kits |
| UPC / GTIN / UDI-DI | 05055273201765 |
| Lot numbers | 588434 |
| Model numbers | CP3826 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1286-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.