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HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit content...

FDA Recall #Z-0736-2016 — Class II — December 18, 2015

Recall #Z-0736-2016 Date: December 18, 2015 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Instrumentation Laboratory Co. — Bedford, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

Domestic: 108 kits, Foreign: 197 kits

Distribution

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.

Code Information

Lot No. N0455811, Expiration Date 03/31/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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