Recall for Troponin I Rapid Test Devices and Myoglobin/CK-MB/Troponin I Combo Test Devices, DIMA
2008.10.21
Product group In-vitro diagnostics
Reference 03090/08, 03091/08
Recall of DIMA Gesellschaft für Diagnostika for Troponin I Rapid Test Devices and Myoglobin/CK-MB/Troponin I Combo Test Devices (Whole Blood/Serum/Plasma), because claimed limit of detection has shifted which may lead to false negative results. The customers were requested to discontinue use, immediately, and discard the affected products.