Siemens Healthcare Diagnostics, Inc. Recall 87590
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.
Siemens Healthcare Diagnostics, Inc. Recall 87590 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1435-2021 |
| Event ID | 87590 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 1547 assays |
| Recall Reason | Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. |
| Device Classification | 20210428 |
| Device Code Info | (UDI) 00630414945514 |
| Center Classification Date | 20210419 |
| Recall Initiation Date | 20210302 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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