2 results
·
38ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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.
FDA Enforcement
Class II
·Terminated·Response Biomedical Corp.·March 18, 2020
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.
FDA Recall
Terminated
·Response Biomedical Corp.
1781 75th Ave W
Vancouver Canada·Product code JJY·March 15, 2019