Z-1867-2012Class II

BCS(R) Behring Coagulation System, Device catalog No. OVIO03

Name: Z-1867-2012 BCS(R) Behring Coagulation System, Device catalog No. OVIO03
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-12-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-12-01 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies on 2010-12-01. FDA classified it as Class II and gives the reason as "Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1867-2012
Classification: Class II
Status: Terminated
Initiated: 2010-12-01
Posted: 2012-06-26
Terminated: 2014-03-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Field Safety Notice dated December 2010 was issued to all BCS(R) System owners. Firm conducted a voluntary field corrective action to notify BCS(R) System owners and to install a software "patch" to resolve the issue. Until the software patch was installed on the BCS(R) System, customers were instructed in the Safety Notice that "the potential issue of carryover can be avoided if the Cleaner SCS vial is kept filled and not allowrd to run empty."
Quantity in commerce: 186
Distribution: Worldwide Distribution - US (nationwide) including the states of: AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MD, MA, MI, MS, MN, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV, and WI and the countries of: Australia, France, Canary Islands, Spain, Belgium, Germany, Switzerland, Netherlands, Italy, Guadeloupe, Ceuta, Austria, Slovenia, Croatia, Saudi Arabia, Turkey, Greece, and San Marino.
Product codes and lots: Device catalog No. OVIO03 (not lot specific)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1867-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1867-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-25

Product code JPA

K013114Class IIBcs SystemDade Behring, Inc. / cleared 2001-11-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)