Recall Z-1867-2012 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Siemens Healthcare Diagnostics, Inc.
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
| Date | Jun 26, 2012 (initiated Dec 1, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013114 | BCS SYSTEM Dade Behring, Inc., Nov 9, 2001 |