Z-0825-2016Class II

BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies...

Name: Z-0825-2016 BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-01-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-01-14 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE)... on 2016-01-14. FDA classified it as Class II and gives the reason as "False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0825-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-14
Posted: 2016-02-19
Terminated: 2017-03-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction Letter (dated 1/12/2016) was sent to US consignees via FedEx on 1/14/2016 and to foreign consignees (distribution is determined at country level). The letter re-emphasizes the importance of checking the interference levels given in the respective Application Sheets of the BCS and BCS XP systems. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 1895 units total
Distribution: Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0825-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0824-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-19
Z-0825-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-19

Product code JPA

K970431Class IIBehring Coagulation SystemBehring Diagnostics, Inc. / cleared 1997-05-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)