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Recall Observatory FDA recall evidence

Device product

Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.

Z-1713-2015

May 11, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 71267
Status
Terminated
Classification
Class II
Quantity
3,575
Official record key
device-enforcement:Z-1713-2015

Official wording

Reason: Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.

Code information: 10454742 10454729 10461894 10470625

Distribution pattern: Worldwide Distribution -- Austria, Bulgaria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia, Bahrain, Belarus, Bosnia-Herzegovina, Guadeloupe, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Qatar, Russia, San Marino, Saudi Arabia, Serbia, South Africa, United Arab Emirates, Argentina, Brazil, Chile, El Salvador, Peru, China, Mexico, Canada and United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.