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Instrumentation Laboratory Co. recalls HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptoki
Recalled February 10, 2016 · FDA recall Z-0736-2016 · Instrumentation Laboratory
Hazard
This Lot is not meeting labeled on-board instrument stability claims of 5 days. · FDA Class II
Units
Domestic: 108 kits, Foreign: 197 kits
Sold at
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.
Description
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
Product
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(s)
Instrumentation Laboratory Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →