Rheumatoid Factor Standard — Class II medical device recall Z-0282-2020
Terminated recall by Randox Laboratories Ltd., reported 2019-11-13, distributed nationwide. The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British st
| Recall number | Z-0282-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2019-08-09 |
| Classified | 2019-11-04 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2021-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 17 kits |
| UPC / GTIN / UDI-DI | 05055273205039 |
| Lot numbers | 1329RF, 1343RF, 1347, 1351RF, 463479/1325, 466715/1325, 474059/1339, 480410 |
| Model numbers | RF2301 |
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.
Machine access
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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.