Randox recalls Serology I Positive Control vials that may test negative for HBsAg, causing delays in patient results. Affected units contain specific lot numbers and expiration dates.
***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
Randox is recalling its Serology I Positive Control vials because they may test negative for HBsAg, leading to delays in reporting patient results. This affects specific lot numbers produced before March 2023.
The positive control vials may test negative for HBsAg (hepatitis B surface antigen) on certain analyzers, causing false negative results. This could delay reporting patient results if the control fails to indicate proper testing function.
Laboratories using Randox Serology I Positive Control vials with lot number 036SR (expired March 2023) are affected. Most at risk are healthcare facilities that rely on this control product for accurate testing.
Check for lot number 036SR on the vial label. The product expires March 28, 2023, and was sold in kits of 3 vials each.
Look for lot number 036SR on the vial label to confirm if it is affected.
The positive control vials may test negative for HBsAg, causing delays in reporting patient results.
The recall record does not specify a remedy, so check the lot number and contact Randox for guidance.
Look for lot number 036SR on the vial label; the product expires March 28, 2023.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1772-2022 — Randox Randox Hello, I own a Randox that is covered by recall Z-1772-2022 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
