Instrumentation Laboratory Co.: Medical Device Recall in 2016 - (Recall #: Z-0736-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 18, 2015

Date Posted: February 10, 2016

Recall Number: Z-0736-2016

Event ID: 72972

Reason for Recall:

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

Status: Terminated

Product Quantity: Domestic: 108 kits, Foreign: 197 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated