543 results
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37ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GJS·August 2, 2017
Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 19, 2007
Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
FDA Recall
Terminated
·Data Innovations, Inc.·Product code JQP·May 11, 2009
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GJS·April 9, 2013
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GGP·December 18, 2015
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
GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.
FDA Recall
Terminated
·Ge Healthcare It·Product code JQP·August 27, 2010
Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code CHL·May 11, 2011
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
FDA Recall
Terminated
·Hologic, Inc·Product code JQW·June 27, 2017
Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GGP·April 11, 2012
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
FDA Recall
Terminated
·Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France·Product code JQP·March 22, 2021
ACL TOP 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, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GKP·July 13, 2023