—#108994

Product

BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies

FDA product code: JPA — System, Multipurpose For In Vitro Coagulation Studies
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K013114
Affected lot / code info: Device catalog No. OVIO03 (not lot specific)

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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."

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-12-01
Posted by FDA: 2012-06-26
Terminated: 2014-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108994. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.