Reported Apr 17, 2013 · Terminated

Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time…

Siemens Healthcare Diagnostics, Inc.

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: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466

Is this the product you have?

  • Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Lot codes and dates
  • Catalog numbers B4219-1 and B4219-2
    • lot numbers 547311
    • exp 3/22/2013
    • 547312
    • exp 3/22/2013 and 547316A
    • exp 4/28/2013
Amount recalled
13,083

Where it was sold

Why it was recalled

Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.

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 Dec 24, 2013 · Data as of Sep 19, 5:33 PM UTC

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