Reported Mar 18, 2020 · Terminated
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number…
Response Biomedical Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Response Biomedical Corp. · 1781 75th Ave W · Vancouver · N/A
Is this the product you have?
- Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318)
- IFU"RAMP Cardiac Controls *** CAT. No.: C2003-2 ***
- Size3 x 3 ML"
- Product Usageuse in the quality control of cardiac marker assays run on the RAMP¿ platform
- Lot codes and dates
- Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318)
- UDI Code(01) 1 0627966 00508 4 (10) 070318 (17)300919
- Amount recalled
- 543 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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