FDA-Device2016-02-10Class II
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
Instrumentation Laboratory Co.
Hazard
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
Sold states
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.
Affected count
Domestic: 108 kits, Foreign: 197 kits
Manufactured in
180 Hartwell Rd, N/A, Bedford, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0736-2016Don't want to check this manually?
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