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