Randox recalls Immunoassay Premium Controls (model IA2633/IA2638) due to incorrect target value on value sheets, potentially affecting diagnostic accuracy. Affected units may need verification.
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 diagnostic controls because their value sheets list an incorrect target value (43.8%U instead of 39.4%U). This could lead to inaccurate test results if used in analyzers.
The value sheet incorrectly states a target uptake value of 43.8%U when it should be 39.4%U. This error could cause inaccurate test results if the analyzer uses the wrong value.
Users of these diagnostic controls for in vitro testing are affected. Laboratory staff and healthcare providers using the products for quality control are most at risk.
Check for model numbers IA2633 or IA2638 on the product. These controls are intended for in vitro diagnostic use and were sold with lot codes 440941 or 1720EC.
Check the model number on the product to confirm it is IA2633 or IA2638.
The value sheet lists an incorrect target uptake value (43.8%U instead of 39.4%U) for the analyzer, which could affect test accuracy.
No specific stop-use instruction is given; users should verify the model and check for the correct target value.
Check the model number and lot code to confirm if the product is affected. No immediate action is required beyond verification.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1105-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-1105-2019 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.
