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.
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. has recalled the Randox Serology I Positive Control (Lot 036SR, expiration date March 28, 2023) because the HBsAg analyte tests negative (Non-Reactive) on the Ortho Vitros and Beckman Couler DxI analyzers, even though it is supposed to test positive. Two units were distributed nationwide in West Virginia and North Carolina.
This defect causes delays in reporting patient test results because the positive control is producing incorrect negative results. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
***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
Reason for recall: ***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 Distribution: US Nationwide distribution in the states of WV, NC. Quantity: 2 units Lot/code info: GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.