# FDA recall Z-0282-2020

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2019-08-09.

## Product

Rheumatoid Factor Standard (RF CAL)  Catalogue Number: RF2301  GTIN: 05055273205039   Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.

## Reason for recall

The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

## Distribution

US Nationwide distribution in the states of WV, ME, NJ, CA,  and Puerto Rico.

## Key facts

- **Recall number:** Z-0282-2020
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-09
- **Report date:** 2019-11-13
- **Termination date:** 2021-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2020

## Citation

> AI Analytics. FDA recall Z-0282-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0282-2020. Source: US FDA. Licensed CC0.

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