BCS XP Automated Blood Coagulation Analyzer System — Class II medical device recall Z-0825-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-03-02, distributed nationwide. False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for f
| Recall number | Z-0825-2016 |
|---|---|
| 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 | 2016-01-14 |
| Classified | 2016-02-19 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-03-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CY, CZ, DE, DK, ES, FI, FR, HR, HU, IT, KW, LB, LV, MX, NL, PE, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TR, UY, ZA |
| Quantity | 1,895 units |
| Model numbers | 10459330 |
Product
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
Reason for recall
False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.
Machine access
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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.