Z-1435-2021 Class II Terminated
FDA device recall Z-1435-2021 was initiated by Siemens Healthcare Diagnostics, Inc. on March 2, 2021 and is designated Class II. 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. The recall status is terminated (terminated June 10, 2022). Affected quantity: 1547 assays.
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- March 2, 2021
- Termination Date
- June 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1547 assays
Product Description
Reason for Recall
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.