The Randox Serology I Positive Control contains the following… — Class II medical device recall Z-1772-2022
Terminated recall by Randox Laboratories Ltd., reported 2022-09-28, distributed nationwide. ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter Dx
| Recall number | Z-1772-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2022-08-01 |
| Classified | 2022-09-19 |
| Reported by FDA | 2022-09-28 |
| Terminated | 2024-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 05055273216509 |
| Lot numbers | 036SR, 28TH |
Product
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1772-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.