Randox recalls Immunoassay Premium Plus Controls (model IA3109/IA3112) due to incorrect target value on value sheet for analyzers. This may affect diagnostic accuracy in lab testing.
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.
Rando: Randox recalls two specific models of lab test controls because the target value on their documentation is wrong. This could lead to inaccurate lab results if used with certain analyzers.
The value sheet lists an incorrect target value (43.8%U) instead of the correct 39.4%U for the analyzer. This mismatch could cause inaccurate lab results if the controls are used with analyzers that rely on this specific value.
Lab technicians and healthcare facilities using these specific test controls for in vitro diagnostics. Those using the controls with analyzers that require precise 39.4%U target values are most at risk.
Check for model numbers IA3109 or IA3112 on the product. These controls are intended for in vitro diagnostic use and were sold with lot codes 1714EC, 430312, or 432364.
Look for model numbers IA3109 or IA3112 on the product label.
The target value for uptake on the value sheet is incorrect (listed as 43.8%U instead of 39.4%U) for analyzers that require precise calibration.
Using these controls with analyzers that require the correct target value could lead to inaccurate lab results.
Check the model number and lot code. If you have the recalled models, contact Randox for guidance.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1106-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-1106-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
