Devices

Device Recall Spectrolyse PAI1

Model / Serial
Lot Numbers: 120425 and 120601
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: USA including states of: FL, IN, IL, and WA.
Product Description
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. || Catalog Number: 101201 || For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Manufacturer
Sekisui Diagnostics Llc
1 Event
- Recall of Device Recall Spectrolyse PAI1

Manufacturer

Sekisui Diagnostics Llc

Manufacturer Address
Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
Manufacturer Parent Company (2017)
Sekisui Chemical Co. Ltd.
Source
USFDA

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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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