Devices

Device Recall Instrumentation Labs Test Plasminogen

Model / Serial
Lot No. N0455811, Expiration Date 03/31/2017
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.
Product Description
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
Manufacturer
Instrumentation Laboratory Co.
1 Event
- Recall of Device Recall Instrumentation Labs Test Plasminogen

Manufacturer

Instrumentation Laboratory Co.

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

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