# FDA recall Z-1772-2022

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2022-08-01.

## 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

## Distribution

US Nationwide distribution in the states of WV, NC.

## Key facts

- **Recall number:** Z-1772-2022
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-08-01
- **Report date:** 2022-09-28
- **Termination date:** 2024-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1772-2022

## Citation

> AI Analytics. FDA recall Z-1772-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1772-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*