167 results
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54ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code LOL·January 12, 2008
ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code MMI·June 7, 2007
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·September 25, 2007
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JJE·February 3, 2014
IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JLS·July 21, 2008
Direct Water feed Kit, Catalog#10373222
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JJE·March 5, 2015
Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JJE·March 5, 2015
Sample Management System software for in vitro diagnostic testing Product # 030102-03
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code CDD·January 15, 2007
Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code DGC·January 5, 2009
Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JHI·October 17, 2007
In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JHI·April 4, 2008
VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code LXG·April 25, 2014
Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JJE·March 5, 2015
Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JJE·March 5, 2015
Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JJE·March 5, 2015
Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JJE·March 5, 2015
COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code LTJ·May 21, 2008
Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions Diagnostics·June 3, 2015
Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions Diagnostics·June 3, 2015
Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions Diagnostics·June 3, 2015