Randox Laboratories product recalled over hepatitis A risk

Recall date

August 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Randox Laboratories Ltd. recalls Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid…

Recall number

Z-0282-2020

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.