Behring Coagulation System

• • Terminated Z-1435-2021 FDA Class II ·initiated 2 Mar 2021

  Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

• • Terminated Z-0825-2016 FDA Class II ·initiated 14 Jan 2016

  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.

510(k) Number

K970431 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Clibration Plasmas

  Class II

  FDA 510(k) K924404 Active Cleared 1 Dec 1992

• Opus Ck-Mb & Total Ck Controls

  Class I

  FDA 510(k) K960275 Active Cleared 25 Apr 1996

• D.A.T. (Tm) Amylase Reagent

  Class II

  FDA 510(k) K871943 Active Cleared 3 Jun 1987

• N/T Protein Control Sl

  Class I

  FDA 510(k) K964065 Active Cleared 6 Nov 1996

• Enzygnost(R) Anti-Cmv Igg

  Class II

  FDA 510(k) K913910 Active Cleared 28 Apr 1992

• N/T Rheumatology Control Sl/1 and Sl/2

  Class II

  FDA 510(k) K962373 Active Cleared 11 Jul 1996

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