Recall for gabControl Troponin I (M04K13) and gabControl CardiaCombo Myoglobin/CK-MB/Troponin I (M05K47), gabmed GmbH
2008.08.20
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.