58 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Recall
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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
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
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
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
FDA Recall
Completed
·Accriva Diagnostics, Inc.·Product code DQA·September 27, 2024
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code JPA·July 23, 2019
ROTEM ex-tem Canada Part No: 503-05-CA
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code JPA·July 23, 2019
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013
ROTEM ex-tem; US Part No: 503-05-US
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code JPA·July 23, 2019
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GJS·October 13, 2021
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
FDA Recall
Open, Classified
·Accriva Diagnostics, Inc.·Product code GGN·April 30, 2026
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