Randox recalls LIA3105 liquid immunoassay controls for inaccurate test results. The target value is listed incorrectly on the value sheet, potentially causing inaccurate lab diagnostics.
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Randox is recalling its LIA3105 liquid immunoassay controls because the target value for uptake is incorrectly listed as 43.8%U instead of 39.4%U. This could lead to inaccurate lab test results if used in diagnostic equipment.
The value sheet for the analyzer shows an incorrect target value (43.8%U instead of 39.4%U). This could cause inaccurate test results when used in diagnostic equipment, but does not pose a physical safety hazard.
Lab technicians and healthcare providers who use these controls for in vitro diagnostic testing may be affected. The risk is low as the issue only impacts test accuracy, not safety.
Check for the model number LIA3105 on the product label. These controls were sold with lot code 1723EC for in vitro diagnostic use.
Look for the model number LIA3105 and lot code 1723EC on the product label.
The target value for uptake is incorrectly listed as 43.8%U instead of 39.4%U on the value sheet, which could lead to inaccurate lab test results.
Check the product label for model number LIA3105 and lot code 1723EC. If you have this product, you may want to contact Randox for further guidance.
No, the recall is for potential inaccurate test results, not a physical safety hazard.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1107-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-1107-2019 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.
