FDAFDA · Food and drugs·Recall number Z-0736-2016
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
Published February 10, 2016 · Recall initiated: December 18, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Instrumentation Laboratory Co.
- Distributor
- 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.
- Lot
- Lot No. N0455811, Expiration Date 03/31/2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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