Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1435-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 2, 2021

Date Posted: April 28, 2021

Recall Number: Z-1435-2021

Event ID: 87590

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.

Status: Terminated

Product Quantity: 1547 assays

Code Information:

(UDI) 00630414945514

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated