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BCS® XP System
Siemens Healthcare Diagnostics Products GmbH · Model 10459330 · UDI-DI 00630414945514
1
510(k) clearances
661
Adverse events (13 deaths)
31
Recalls
17
Facilities
Description
The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-13 | Instrumentation Laboratory | Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result |
| 2022-02-22 | Instrumentation Laboratory | Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when Hemo |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2013-07-19 | Instrumentation Laboratory Co. | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. |
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