The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/

FDA device recall Z-1772-2022 · posted 2022-09-19 · Terminated

Recall details

Recalling firm

Randox Laboratories Ltd.

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

Action taken

****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.

Root cause

Process change control

Status

Terminated

Product code

OHQ

Quantity affected

2 units

Distribution

US Nationwide distribution in the states of WV, NC.

Date initiated

2022-08-01

Date posted

2022-09-19

Date terminated

2024-12-13

Location

Crumlin, North, Ireland