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.
FDA Recall Z-1713-2015 · Posted 2015-06-05
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeGJT
Date Initiated2015-05-11
Date Terminated2017-09-12
Product Quantity3,575
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.
Firm Action
An Urgent Medical Device Recall notice, dated May 2015, was sent to affected customers to inform them about the issue and associated risks. Customers were asked to discontinue use, distribute this information to all appropriate personnel, and to complete and fax back to Siemens the Effectiveness Check form.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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