Devices

Instrumentation Laboratory

Model / Serial
Serial Number range: 08010100-10061231
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution, USA and Canada
Product Description
ACL TOP 500 CTS || PN 000280040 || 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.
Manufacturer
Instrumentation Laboratory Co.
1 Event
- Recall of Instrumentation Laboratory

Manufacturer

Instrumentation Laboratory Co.

Manufacturer Address
Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
USFDA

13 devices with a similar name

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Device Recall Instrumentation Laboratory (IL)

Model / Serial
Lot Number: 306355 Expires: 8/31/2003
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
CA, FL, NY, PA, TN,
Product Description
GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. || Part No. 24330004 (300 Sample Size) || For In-Vitro Diagnostic Use
Manufacturer
Instrumentation Laboratory Co.

Device Recall Instrumentation Laboratory (IL)

Model / Serial
Lot Number: 306360 Expires: 8/31/2003
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
CA, FL, NY, PA, TN,
Product Description
GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. || Part No. 24345004 (450 Sample Size) || For In-Vitro Diagnostic Use
Manufacturer
Instrumentation Laboratory Co.

Device Recall Instrumentation Laboratory

Model / Serial
Software prior to Version V3.5
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Florida Canada
Product Description
ACL Futura Instrument Analyzer
Manufacturer
Instrumentation Laboratory Co.

Device Recall Instrumentation Laboratory

Model / Serial
Software version prior to V2.1
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Florida Canada
Product Description
ACL Advance Instrument Analyzer
Manufacturer
Instrumentation Laboratory Co.

Device Recall Instrumentation Laboratory

Model / Serial
Serial numbers starting with 18412
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Foreign: Canada
Product Description
GEM PREMIER 3000
Manufacturer
Instrumentation Laboratory Co.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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