Response Biomedical recalls Randox Cardiac Control (C2003-2) due to potential CK-MB level decreases in test results. Affected units have a 24-month shelf life and may cause inaccurate cardiac test results.
The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.
Response Biomedical is recalling Randox Cardiac Control test kits that may show falsely low CK-MB levels in cardiac tests. This could lead to incorrect cardiac health assessments if used without the recall fix.
The test kit may show up to 57% lower CK-MB levels than expected within 11 months of production. This could cause cardiac test results to be inaccurate, potentially leading to incorrect health assessments.
Healthcare professionals using Randox Cardiac Control test kits for cardiac marker assays on the RAMP platform. Those who have the specific lot numbers are most at risk of inaccurate test results.
Check for Randox Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318). The product is used for cardiac marker assays on the RAMP platform.
Verify the product's Catalogue Number and Lot Number to confirm if it's affected.
The product may show up to 57% lower CK-MB levels than expected within 11 months, causing inaccurate cardiac test results.
Check the product details to confirm if it's affected; the recall does not require immediate action but may need correction for accurate results.
The product has a 24-month shelf life from the date of manufacture.
We’ve drafted a message you can send Response Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1461-2020 — Response Biomedical Response Biomedical Hello, I own a Response Biomedical that is covered by recall Z-1461-2020 from Response Biomedical. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
