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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.

Recall for Troponin I Rapid Test Devices and Myoglobin/CK-MB/Troponin I Combo Test Devices, DIMA , Download_VeroeffentlichtAm_EN PDF, 136KB, File does not meet accessibility standards