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.
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics Products GmbH has recalled the BCS XP System, a device used for blood coagulation testing, due to a potential carryover of Emicizumab (a clotting factor treatment) on patient samples. The affected product codes are 10459330, 10461894, and 10470625. A total of 1,547 assays with UDI 00630414945514 have been distributed worldwide, including across the United States and multiple countries in Europe, South America, and other regions.
The recall affects facilities in numerous U.S. states and internationally distributed locations. The source document does not specify a remedy or recommended action for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
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. 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 Quantity: 1547 assays Lot/code info: (UDI) 00630414945514
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.