Reported Jul 31, 2013 · Terminated

TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

Haemonetics Corporation

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: Haemonetics Corporation · 400 Wood Road · Braintree, MA · 02184-2412

Is this the product you have?

  • TEG 5000 Thromboelastograph
  • Coagulation Analyzer Product UsageMultipurpose System for In Vitro Coagulation Studies
Lot codes and dates
  • Per recall strategy.
Amount recalled
1590 devices

Where it was sold

  • Nationwide

Why it was recalled

Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

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 Jun 4, 2015 · Data as of Sep 19, 4:51 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.