FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1772-2022
- Recalling firm
- Randox Laboratories Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2022-08-01
- Posted
- 2022-09-19
- Terminated
- 2024-12-13
- 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: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Randox issued Urgent Medical Correction Notification (REC611) dated August 2, 2022 to the distribution center within the USA. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. Letter states reason for recall, health risk and action to take: Randox Serology I Positive Control SR10352 lot 036SR will test negative (Non-Reactive) for Marker HBsAg using the Beckman Coulter Dxl method. The Positive control will produce a Reactive result on the Abbott Alinity, Siemens Atellica and Biomerieux Vidas methods. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to tech nical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of WV, NC.
- Lot, serial or model codes
- GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHQ
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28