Randox recalls Immunoassay Premium Control Tri Level kits for potential delay in reporting test results due to quality control issues. Affected kits have specific batch numbers and expiration dates.
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 Control Tri Level kits used for quality control in lab tests. These kits may cause delays in reporting test results if the quality control values are outside the expected range.
The quality control kits may show values outside the expected range when used with Roche Cobas e801 analyzers. This can cause delays in reporting test results because the analyzer might not recognize the quality control values correctly.
Lab users who have the Immunoassay Premium Control Tri Level kits with batch number 583135 or lot 2031EC are affected. Those using these kits for quality control in lab tests are most at risk.
Check for batch number 583135 or lot 2031EC on the kit. The expiration date is April 28, 2023. These kits are used for quality control in lab tests.
Look for batch number 583135 or lot 2031EC and expiration date of April 28, 2023 on the kit.
The quality control values may be outside the expected range when used with Roche Cobas e801 analyzers, causing delays in reporting test results.
Check the batch number and expiration date. If it matches 583135 or lot 2031EC with an expiration date of April 28, 2023, contact Randox for guidance.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2022-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-2022-2023 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.
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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.
