Siemens Healthcare recalls BCS XP System units with product codes 10459330, 10461894, 10470625 due to potential emicizumab carryover in patient samples affecting coagulation test results.
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
Siemens Healthcare is recalling BCS XP System units used for coagulation tests because they may have emicizumab carryover in patient samples. This could lead to inaccurate test results, though the recall does not mention immediate safety risks to users.
The BCS XP System may have emicizumab carryover from previous tests, which can contaminate patient samples. This could lead to inaccurate coagulation test results, potentially affecting medical decisions.
Users of the BCS XP System for coagulation testing are affected. Healthcare professionals and labs using these units with product codes 10459330, 10461894, or 10470625 are most at risk.
Check for product codes 10459330, 10461894, or 10470625 on the BCS XP System. The system is used for in vitro coagulation studies and has a unique device identifier (UDI) 00630414945514.
Verify your BCS XP System has one of the product codes 10459330, 10461894, or 10470625.
The BCS XP System may have emicizumab carryover in patient samples, which could lead to inaccurate coagulation test results.
Check if your system has product codes 10459330, 10461894, or 10470625. If so, contact Siemens Healthcare for further instructions.
The recall does not mention any safety risks to users; it focuses on potential inaccurate test results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1435-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1435-2021 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
