Reported Feb 10, 2016 · Terminated

HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL…

Instrumentation Laboratory Co.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instrumentation Laboratory Co. · 180 Hartwell Rd · Bedford, MA · 01730-2443

Is this the product you have?

  • HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company
  • Kit contents2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Lot codes and dates
    • Lot No. N0455811
    • Expiration Date 03/31/2017
Amount recalled
Domestic: 108 kits, Foreign: 197 kits

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 30, 2017 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.