Randox recalls Liquid Cardiac Control CQ5052 due to unacceptable variation between vials affecting Troponin T assay accuracy. Affected units may cause incorrect test results.
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
Randox is recalling Liquid Cardiac Control CQ5052 vials because they have unacceptable variation that could lead to incorrect Troponin T test results. This affects laboratory use where precise cardiac tests are needed.
The vials show unacceptable variation in their chemical composition, which can cause inconsistent test results for Troponin T. This variation means the product may not reliably measure cardiac damage markers.
Laboratories using Liquid Cardiac Control CQ5052 for Troponin T assays are affected. Those performing cardiac tests with this product are most at risk of inaccurate results.
Check for the product name 'Liquid Cardiac Control CQ5052' on the vial label. All lots are affected by this recall.
Look for the product name 'Liquid Cardiac Control CQ5052' on the vial label to confirm if it is affected.
Randox has confirmed that Liquid Cardiac Control CQ5052 vials have unacceptable variation between vials, which can cause inconsistent Troponin T assay results.
The recall record does not specify a remedy or fix for this product.
Check the vial label for 'Liquid Cardiac Control CQ5052' — all lots are affected by this recall.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0381-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-0381-2019 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.
