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.

Recall Insight

This FDA Devices action (record #Z-1461-2020) was formally reported on March 18, 2020, with the manufacturer initiating the action on March 15, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Response Biomedical Corp. is listed as the recalling firm, operating out of Vancouver. Federal records indicate 543 units units are affected.

The documented reason for this recall is: 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 l… Distribution data in the federal record shows the product reached: 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, Dominica…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.