Randox Laboratories Ltd. recalls The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1…

Recall date

August 1, 2022

Source

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

Recall number

Z-1772-2022

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide distribution in the states of WV, NC.

Why it was recalled

***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg

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

What was recalled

The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.