Factor deficient plasma for the Siemens BCS / BCS XP System recallZ-1713-2015 · Siemens Healthcare Diagnostics, Inc. · initiated May 11, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1713-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 11, 2015
- Posted by the FDA
- Jun 5, 2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3,575
- Product code
- GJT
- FDA submissions
- K924396
- 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 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.
Code information (models, lots, serial numbers)
10454742 10454729 10461894 10470625
Other devices under the same FDA submission
2 devices cleared under K924396 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Coagulation Factor IX Deficient Plasma 10446414Siemens Healthcare Diagnostics Products GmbH · PLASMA, COAGULATION FACTOR DEFICIENT5 reports
- Coagulation Factor VIII Deficient Plasma 10446411Siemens Healthcare Diagnostics Products GmbH · PLASMA, COAGULATION FACTOR DEFICIENT3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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