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Recall Observatory FDA recall evidence

Device 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.

Z-1772-2022

August 01, 2022

Class II

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 90777
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1772-2022

Official wording

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

Code information: GTIN: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023

Distribution pattern: US Nationwide distribution in the states of WV, NC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ***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