FDA Device recall Z-1772-2022
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,…
- FDA Device
- Class II
- terminated
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class II recall of 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,… by Randox Laboratories, citing ***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-Reactiv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1772-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-01 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
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
***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
Identifiers
| code_info | GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1772-2022%22
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