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 547311exp 3/22/2013547312exp 3/22/2013 and 547316Aexp 4/28/2013
- Catalog numbers B4219-1 and B4219-2
- 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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