Randox recalls Chemistry QC Premium Plus (LAL4213) due to incorrect sodium control target values for in vitro diagnostics. This may affect lab accuracy in diagnostic testing.
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Randox is recalling its Chemistry QC Premium Plus test kits because the sodium control target values are incorrectly set. This could lead to inaccurate lab results if used in diagnostic testing.
The sodium control target values are set incorrectly for the indirect ISE method. This could cause inaccurate test results if the control kit is used in diagnostic quality control processes.
Lab technicians and healthcare facilities using this product for in vitro diagnostic testing. Those using the control kit for quality assurance in diagnostic labs are most at risk.
Check for the product name 'Chemistry QC Premium Plus', catalog number LAL4213, and GTIN 05055273209006. The recall applies to lot 306UL.
Verify the catalog number (LAL4213) and GTIN (05055273209006) on the product label.
The product is intended for in vitro diagnostic use but has incorrect sodium control values. It should not be used for quality control until the recall is addressed.
Check the product details to confirm if it's affected. If it is, contact Randox for guidance on next steps.
Incorrect sodium control values could lead to inaccurate test results in diagnostic quality control processes.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1547-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-1547-2020 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.
