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Thrombelastograph Coagulation Analyzer Teg-5000 Series

by Haemoscope Corp.

510(k) K002177

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002177 Date14 Sep 2000ClearedStatusActive

Recalls

7 recalls · FDA

    • Terminated Z-1310-2022 FDA Class II initiated 26 Apr 2022

    Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

    • Terminated Z-1298-2022 FDA Class II initiated 19 Apr 2022

    When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

    • Terminated Z-1617-2020 FDA Class II initiated 19 Feb 2020

    Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.

    • Terminated Z-1130-2015 FDA Class II initiated 26 Jan 2015

    Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.

    • Terminated Z-1796-2013 FDA Class II initiated 20 Jun 2013

    Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

    • Terminated Z-2742-2011 FDA Unclassified (pre-2012) initiated 4 Mar 2011

    Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).

    • Terminated Z-1738-2011 FDA Unclassified (pre-2012) initiated 28 Jan 2011

    Haemonetics has received a report of smoke from the unit with a power supply failure.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JPA
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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