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.

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.