FDA-Device2012-07-04Class II
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
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.
Affected count
186
Manufactured in
500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, United States
Products
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1867-2012Don't want to check this manually?
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