Recall for One Step Troponin I Raid Test Devices and One Step Myoglobin/CK-MB/Troponin I Combo Test Device
2008.09.09
Product group In-vitro diagnostics
Reference 02740/08
Recall of Innovacon for cTnI-One Step Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) and One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole Blood/Serum/Plasma) disturbed under the brands of ACON, On-Call and Quick-Check catalog no. CTI-402 and CMA-435 because the claimed limit of detection has shifted. The customers were requested to discontinue all use and discard all affected product, immediately. (Lot numbers: see Appendix A in the German Customer Letter).