Recall Z-1772-2022 ยท OHQ Multi-Analyte Controls Unassayed
Randox Laboratories Ltd.
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.
| Date | Sep 19, 2022 (initiated Aug 1, 2022) |
| Status | Terminated |
| Reason | ***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 |
| Root cause | Process change control |
| Action | ****UPDATE*** Randox issued Updated Urgent Medical Device Correction REC611 Rev 2 dated 10/7/22. Letter states: The Randox Serology I Positive Control SR10352 lot 036SR will test negative (Non-Reactive) for Marker HBsAg using the Beckman Coulter Dxl and Ortho Vitros methods. Randox can confirm the Positive control will produce a Reactive result on the Abbott Alinity, Siemens Atellica, Biomerieux Vidas and Roche e411 methods. Randox cannot guarantee that the control will produce a Reactive result on methods not included on this notice. The distributors and customers will be instructed to: " Dis |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of WV, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.