FDAFDA · Food and drugs·Recall number Z-1867-2012
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Published July 4, 2012 · Recall initiated: December 1, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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.
- Lot
- Device catalog No. OVIO03 (not lot specific)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.