Randox recalls Immunoassay Premium Level 3 quality control kits for potential delays in test results due to high recovery values outside the acceptable range on Roche Cobas e801 analyzers.
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Randox is recalling Immunoassay Premium Level 3 quality control kits that may cause delays in test results when used with Roche Cobas e801 analyzers. This happens because the test results show high recovery values outside the expected range, which can lead to inaccurate test reporting.
The quality control kits may show high recovery values outside the acceptable range when used with Roche Cobas e801 analyzers. This can cause delays in reporting test results, potentially affecting the accuracy of hormone tests like ACTH.
Healthcare facilities using Randox Immunoassay Premium Level 3 kits with Roche Cobas e801 analyzers are likely affected. Those using the kits for hormone testing, particularly ACTH, are at the highest risk.
Check for the catalog number IA2640 and lot number 2031EC on the kit. The expiration date is November 28, 2023. These kits were sold with Roche Cobas e801 analyzers.
Verify the catalog number (IA2640) and lot number (2031EC) on the kit to confirm it is recalled.
The recall is happening because the quality control kits may show high recovery values outside the acceptable range when used with Roche Cobas e801 analyzers, causing delays in test results.
The official recall notice does not specify a remedy or action steps for affected kits.
The recall indicates a potential delay in test results, but the official notice does not state that this poses a direct health risk.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2021-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-2021-2023 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.
