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Recall Observatory FDA recall evidence

Device 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

Z-0736-2016

December 18, 2015

Class II

Product summary

Firm
Instrumentation Laboratory Co.
Event
Event 72972
Status
Terminated
Classification
Class II
Quantity
Domestic: 108 kits, Foreign: 197 kits
Official record key
device-enforcement:Z-0736-2016

Official wording

Reason: This Lot is not meeting labeled on-board instrument stability claims of 5 days.

Code information: Lot No. N0455811, Expiration Date 03/31/2017

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This Lot is not meeting labeled on-board instrument stability claims of 5 days.