Skip to content

Teg Hemostasis System 07-012

by Haemonetics Corporation

Teg Hemostasis System 07-012 is a Class II device made by Haemonetics Corporation, cleared under FDA 510(k) K002177 on 14 Sep 2000 (1 earlier submission) and listed in FDA GUDID since 31 Jul 2017 (UDI-DI 10812747018043), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10812747018043 UDI-DI Date31 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002177 Date14 Sep 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002177 decided 14 Sep 2000 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10812747018043 listed 31 Jul 2017 Listed

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.

Timeline

10 dated events

  1. Cleared FDA 510(k) K993678
  2. Cleared FDA 510(k) K002177
  3. Recall initiated FDA recalls Z-1738-2011
  4. Recall initiated FDA recalls Z-2742-2011
  5. Recall initiated FDA recalls Z-1796-2013
  6. Recall initiated FDA recalls Z-1130-2015
  7. Listed FDA GUDID 10812747018043
  8. Recall initiated FDA recalls Z-1617-2020
  9. Recall initiated FDA recalls Z-1298-2022
  10. Recall initiated FDA recalls Z-1310-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Teg Hemostasis System
Generic name
Calcium chloride coagulation reagent IVD
Model / reference
07-012
Primary DI / UDI-DI
10812747018043
510(k) Number
FDA product code
JPA
GMDN term
Calcium chloride coagulation reagent IVD
Device class
Class II
Regulation number
864.5425
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Related devices

Category: Calcium chloride coagulation reagent IVD

Cleared under the same submission (K993678)

and 6 more cleared under K993678

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)