Randox recalls urine control kits with potential for incorrect hCG and cortisol results, causing delays in patient testing. Affected kits may have vial variations or transcription errors in instructions.
(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.
Randox is recalling urine control kits used for lab testing because some vials show false positive hCG results and cortisol levels outside normal ranges. This can delay patient test results and lead to incorrect diagnoses.
The kits sometimes show false positive hCG results and cortisol levels outside the expected range. There's also a transcription error in the instructions for creatinine testing, which can cause delays in patient results.
Healthcare labs using Randox Liquid Urine Control Level 2 kits for in vitro diagnostics are affected. Labs testing for hormones like cortisol or pregnancy hormones are most at risk.
Check for the catalog number UC5074 or GTIN 05055273207569 on the kit. The batch number starts with 1209UC and expires by March 28, 2024.
Verify the catalog number UC5074 or GTIN 05055273207569 on the kit label.
The recall is due to vial-to-vial variation causing false positive hCG results and cortisol levels outside the expected range, plus a transcription error in creatinine instructions.
Incorrect results can delay patient testing and lead to wrong diagnoses, especially for hormone tests like cortisol or pregnancy tests.
The official notice doesn't specify a remedy, so labs should check the kit details and 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-2446-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-2446-2023 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.
