Recall Z-1461-2020 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Response Biomedical Corp.
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.
| Date | Mar 15, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 approp |
| Quantity | 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 Philip |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 Randox Laboratories Limited, Jan 23, 2012 |