Z-1713-2015Class II

Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the...

Name: Z-1713-2015 Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-05-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-05-11 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2015-05-11. FDA classified it as Class II and gives the reason as "Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1713-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-11
Posted: 2015-06-05
Terminated: 2017-09-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: GJT Plasma, Coagulation Factor Deficient
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 3,575
Distribution: 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.
Product codes and lots: 10454742 10454729 10461894 10470625

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1713-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1713-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-04

Product code GJT

K924396Class IIClotting Factor-VIII-IX-XI-XII Deficient PlasmaBehring Diagnostics, Inc. / cleared 1993-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)