Siemens Healthcare BCS XP System Recall: Emicizumab Carryover Risk in Coagulation Tests
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.
Lower-risk recall
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63174-siemens-healthcare-bcs-xp-system-recall-emicizumab-carryover-risk-in.
Source Summary by GovInfoNow · govinfonow.com/recall/63174-siemens-healthcare-bcs-xp-system-recall-emicizumab-carryover-risk-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1435-2021
Cite this page
“Siemens Healthcare BCS XP System Recall: Emicizumab Carryover Risk in Coagulation Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63174-siemens-healthcare-bcs-xp-system-recall-emicizumab-carryover-risk-in. Based on FDA recall #Z-1435-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1435-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Category
Medical device
What to do — step by step
Check Product Codes
Verify your BCS XP System has one of the product codes 10459330, 10461894, or 10470625.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 32 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1435-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1435-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.