BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Recall for gabControl Troponin I (M04K13) and gabControl CardiaCombo Myoglobin/CK-MB/Troponin I (M05K47), gabmed GmbH

Product group In-vitro diagnostics
Reference 02936/08, 02939/08

Recall of gabmed GmbH for gabControl Troponin I (M04K13) and gabControl CardiaCombo Myoglobin/CK-MB/Troponin I (M05K47) 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 gabControl Troponin I (M04K13) and gabControl CardiaCombo Myoglobin/CK-MB/Troponin I (M05K47), gabmed GmbH , Download_VeroeffentlichtAm_EN PDF, 144KB, File does not meet accessibility standards