Recall Z-1435-2021 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Mar 2, 2021 |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. |
| Root cause | Under Investigation by firm |
| Action | On 03/17/2021, Siemens issued an Urgent Medical Device Correction notice via email and letter informing customers Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970431 | BEHRING COAGULATION SYSTEM Behring Diagnostics, Inc., May 5, 1997 |