# FDA recall Z-1286-2023

> **Randox Laboratories** · Class II · device recall initiated 2023-02-01.

## 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

## Distribution

PA, OH, WV

## Key facts

- **Recall number:** Z-1286-2023
- **Recalling firm:** Randox Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-01
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kearneysville, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2023

## Citation

> AI Analytics. FDA recall Z-1286-2023. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1286-2023. Source: US FDA. Licensed CC0.

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