Randox Laboratories Ltd.: Medical Device Recall in 2022 - (Recall #: Z-1772-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 1, 2022

Date Posted: September 28, 2022

Recall Number: Z-1772-2022

Event ID: 90777

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

Status: Terminated

Product Quantity: 2 units

Code Information:

GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023

Distribution Pattern:

US Nationwide distribution in the states of WV, NC.

Voluntary or Mandated:

Voluntary: Firm initiated