BCS(R) Behring Coagulation System recall
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Why was BCS(R) Behring Coagulation System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device catalog No. OVIO03 (not lot specific)
- Product
- BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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, Switzerland, Netherlands, Italy, Guadeloupe, Ceuta, Austria, Slovenia, Croatia, Saudi Arabia, Turkey, Greece, and San Marino.
- Recall date
- July 4, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)