Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System — Class II medical device recall Z-1713-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-06-10. Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower
| Recall number | Z-1713-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-05-11 |
| Classified | 2015-06-04 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2017-09-12 |
| Countries outside the US | AE, AR, AT, BE, BG, BH, BR, CA, CH, CL, CN, CY, CZ, DE, DK, HR, IT, KW, LB, LV, MX, NL, PE, PL, PT, QA, RO, RS, RU, SA, SE, SI, SK, SV, TR, ZA |
| Quantity | 3,575 |
Product
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
Reason for recall
Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.
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-1713-2015. 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.