FDA-Device2015-06-10Class II
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.
Siemens Healthcare Diagnostics, Inc.
Hazard
Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.
Sold states
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.
Affected count
3,575
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1713-2015Don't want to check this manually?
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