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Sources: EU EUDAMED, US FDA
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Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Array; the system consists of two devices. The first is a system of capital equipment referred to as CERSR Electromyography System, which includes a cart. The second device is disposable electrodes arrays, which are single use devices, used with the capital equipment that is adhered to the patient for monitoring the bioelectric signals produced by the muscles. The disposable is referred to as the Electrode Array. CERSR Electromyography System is packaged in a reusable crate maintained by SMI. The Electrode Array is packaged in a sealed foil pouch. Both devices are non-sterile and the packaging is for protection from damage during shipping.
FDA Recall
Terminated
·SpineMatrix Inc·Product code IKN·January 29, 2010
ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·November 23, 2016
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 14, 2018
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
FDA Recall
Terminated
·Boston Scientific Corporation·Product code LWP·December 10, 2015
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code LWP·December 10, 2015
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 28, 2016
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CFL·April 15, 2016
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code MMI·November 11, 2015
i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code MMI·September 29, 2011
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
FDA Enforcement
Class I
·Terminated·Alere San Diego, Inc.·July 18, 2012
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code NBC·May 22, 2012
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 9, 2020
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 14, 2020
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MMI·August 19, 2020
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MMI·July 24, 2020
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MMI·October 27, 2014
Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code MMI·March 12, 2012