FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: 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.
- Recall number
- Z-1713-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-05-11
- Posted
- 2015-06-05
- Terminated
- 2017-09-12
- Reason
- Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.
- 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
- 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.
- Lot, serial or model codes
- 10454742 10454729 10461894 10470625
- 510(k) numbers
- ["K924396"]
- PMA numbers
- not on file
- Product code
- GJT
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28