Siemens Healthcare Diagnostics, Inc. - Class 2 Recall
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 7, 2022 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Class 2 Recall
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 7, 2022 Category: Medical Devices Source Type: alerts
Roche Diagnostics Operations, Inc. - Elecsys Troponin I STAT Immunoassay - Class 2 Recall
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2021 Category: Medical Devices Source Type: alerts
Roche Diagnostics Operations, Inc. - Elecsys Troponin I Immunoassay - Class 2 Recall
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2021 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - Class 2 Recall
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - Class 2 Recall
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC TREK Coronary Dilatation Catheter - Class 1 Recall
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2020 Category: Medical Devices Source Type: alerts
