Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1713-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 11, 2015

Date Posted: June 10, 2015

Recall Number: Z-1713-2015

Event ID: 71267

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,575

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.

Voluntary or Mandated:

Voluntary: Firm initiated