Randox recalls Liquid Cardiac Control CQ5053 due to unacceptable variation in Troponin T assay results. Affected units may cause inaccurate 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 CQ5053 products because they cause inconsistent results in Troponin T blood tests. This could lead to inaccurate medical diagnoses if used without replacement.
The product causes inconsistent results in Troponin T blood tests due to unacceptable variation between vials. This variation can lead to inaccurate medical diagnoses if the product is used without replacement.
Healthcare professionals using the Liquid Cardiac Control CQ5053 for Troponin T blood tests are affected. Patients relying on accurate test results may be at risk of incorrect diagnoses.
Check for Liquid Cardiac Control CQ5053 products with any lot number. The recall covers all lots of this product.
Identify the lot number on your Liquid Cardiac Control CQ5053 product.
Randox has confirmed that Liquid Cardiac Control CQ5053 causes unacceptable variation in Troponin T assay results, leading to inconsistent test results.
Check the lot number on your Liquid Cardiac Control CQ5053 product. The recall covers all lots of this product.
The official recall does not specify a fix or remedy for this product.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0382-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-0382-2019 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.
