Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0825-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-01-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0825-2016
Date of alert
2016-01-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10459330
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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