Z-1772-2022 Class II Terminated
FDA device recall Z-1772-2022 was initiated by Randox Laboratories Ltd. on Aug 1, 2022 and is designated Class II. 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… The recall status is terminated (terminated Dec 13, 2024). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2022
- Initiation Date
- Aug 1, 2022
- Termination Date
- Dec 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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.
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 Pattern
US Nationwide distribution in the states of WV, NC.
Code Information
GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1772-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026