Response Biomedical Corp. recalls Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number…

Recall date

March 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1461-2020

FDA classification

Class II

Brand / firm

Response Biomedical Corp.

Sold / distributed

Worldwide distribution: US Nationwide distributions in the states of IN, GA, OK, KS, AZ, SC, NE, NC, MI, FL, CA, MN, and AR. Countries of Canada, Italy, Malaysia, Kuwait, Saudi Arabia, UAE, Ukraine, Russia, Dominican Republic, France, Mexico, Colombia, Singapore, China, Serbia, Romania, and Philipp…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.