BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation
FDA device recall Z-1867-2012 · posted 2012-06-26 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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."
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 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
- Date initiated
- 2010-12-01
- Date posted
- 2012-06-26
- Date terminated
- 2014-03-05
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BCS SYSTEM (K013114) | Dade Behring, Inc. | 2001-11-09 |