FDA Device recall Z-1286-2023
CRP Immunoturbidimetric reagent
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of CRP Immunoturbidimetric reagent by Randox Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1286-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-01 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | OH, PA, WV |
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
Identifiers
| code_info | GTIN: 05055273201765 Batch: 588434 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1286-2023%22
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