35 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 3, 2012
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 3, 2012
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 3, 2012
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 3, 2012
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 3, 2012
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 3, 2012
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013
ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013
ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013
ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013
ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013
ACL TOP 500 CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP 300 CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP (Base), automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP 700 CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP 700, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP 700 LAS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014