Randox recalls Liquid Cardiac Control Level : Unacceptable variation in Troponin T assay results may delay critical cardiac marker testing. Affected lots include 4245CK.
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
Randox is recalling Liquid Cardiac Control Level 3 (cat. no. CQ5053) because it has unacceptable variation in Troponin T assay results, which could delay critical cardiac marker testing. This affects lab equipment used for cardiac diagnostics.
The device shows up to 28% variation between vials, causing quality control results to fall outside acceptable ranges. This could delay reporting Troponin T results, which are critical for cardiac diagnostics, but does not cause immediate harm to patients.
Lab technicians and healthcare facilities using this product for cardiac marker testing. The risk is low as the issue only affects quality control results, not patient safety directly.
Check for the product name 'Liquid Cardiac Control - Level 3' with catalog number CQ5053. The affected lot number is 4245CK. This product is used in clinical labs for cardiac marker testing.
Identify the lot number on the product label; affected units have lot number 4245CK.
The device has unacceptable variation in Troponin T assay results, which could delay critical cardiac marker testing.
The recall record does not specify a remedy, so check the lot number and contact Randox for further instructions.
No, the issue only affects quality control results and does not cause immediate harm to patients.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2575-2018 — Randox Randox Hello, I own a Randox that is covered by recall Z-2575-2018 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.
