Randox recalls Liquid Cardiac Control CQ5051 due to unacceptable variation between vials affecting Troponin T assay accuracy. Affected units include all lots of this product.
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 CQ5051 because vials show unacceptable variation, which can lead to inaccurate Troponin T assay results. This affects medical testing accuracy and could impact patient care if used improperly.
The product has unacceptable variation between vials, meaning test results for Troponin T may be inaccurate. This variation could lead to incorrect medical decisions if the product is used without proper quality control.
Healthcare facilities using Liquid Cardiac Control CQ5051 for Troponin T assays are affected. Patients receiving inaccurate test results due to this variation are at risk.
Check for the product name 'Liquid Cardiac Control CQ5051' on the label. All lots of this product are affected by the recall.
Look for the product name 'Liquid Cardiac Control CQ5051' on the label to confirm if it is affected.
No, Randox has confirmed that Liquid Cardiac Control CQ5051 is no longer suitable for Troponin T assays due to unacceptable variation between vials.
Check the product label for 'Liquid Cardiac Control CQ5051' and contact Randox for further instructions.
The recall specifically affects Liquid Cardiac Control CQ5051. Other products like CQ5052 and CQ5053 were previously recalled but are not part of this specific recall.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0380-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-0380-2019 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.
