BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
Reported: April 28, 2021 Initiated: March 2, 2021 #Z-1435-2021
Product Description
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
Reason for Recall
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1547 assays
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the countries of Argentina, Austria, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lebanon, Macedonia, Mexico, Montenegro, Netherlands, P. R. China, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Uruguay.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1547 assays.
Why was this product recalled? ▼
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Moderate. Recall number: Z-1435-2021.
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