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U.S. Department of Health and Human Services

Class 2 Device Recall RAMP Cardiac Control Level 2

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  Class 2 Device Recall RAMP Cardiac Control Level 2 see related information
Date Initiated by Firm March 15, 2019
Create Date March 10, 2020
Recall Status1 Terminated 3 on June 09, 2022
Recall Number Z-1461-2020
Recall Event ID 84514
510(K)Number K110534  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Response Biomedical Corp.
1781 75th Ave W
Vancouver Canada
For Additional Information Contact
604-456-6045
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action On 03/15/2019, the firm sent an "Field CORRECTION" Letter via email informing them that the specific lot (4244CK) has seen a decrease in CK-MB levels of up to 57% signal loss within 11 months of the Randox-stated shelf life of 24 months. Customers are instructed to: -Inspect their stock levels and report level of unused inventory; -Notify the Recalling Firm's Technical Support using Field Correction Response Form indicating the replacement quantity; -Confirm lot-specific ranges per website (www.responsebio.com/cardiaccountrols) -Substitute affected Lot # 070318 with replacement stock as appropriate. For any further questions or information contact Technical Support at techsupport@responsebio.com.
Quantity in Commerce 543 units
Distribution 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 Philippine.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = RANDOX LABORATORIES LIMITED
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