BCS XP System: Multipurpose system for in vitro coagulation studies — Class II medical device recall Z-1435-2021
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2021-04-28, distributed nationwide. Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potenti
| Recall number | Z-1435-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2021-03-02 |
| Classified | 2021-04-19 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2022-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BR, CA, CH, CN, CY, CZ, DE, DK, ES, FI, FR, GR, HR, HU, IT, LB, MX, NL, PE, PL, PT, RS, SA, SE, SG, SI, SK, TR, UY |
| Quantity | 1,547 assays |
| UPC / GTIN / UDI-DI | 00630414945514 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1435-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.