Z-1435-2021Class II

BCS XP System: Multipurpose system for in vitro coagulation studies

Name: Z-1435-2021 BCS XP System: Multipurpose system for in vitro coagulation studies
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-03-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-03-02 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System... on 2021-03-02. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1435-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-02
Posted: 2021-04-19
Terminated: 2022-06-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
FDA root cause: Under Investigation by firm
Action: On 03/17/2021, Siemens issued an Urgent Medical Device Correction notice via email and letter informing customers Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
Quantity in commerce: 1547 assays
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the countries of Argentina, Austria, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lebanon, Macedonia, Mexico, Montenegro, Netherlands, P. R. China, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Uruguay.
Product codes and lots: (UDI) 00630414945514

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1435-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1435-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-19

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