Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Randox Serology I Positive Control contains the following analytes Recalled by Randox Laboratories Ltd. Due to ***Update** :HBsAg analyte is also Non-Reactive on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories Ltd. directly.
Affected Products
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.
Quantity: 2 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Randox Laboratories Ltd.
Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report