Home / Recalls / Haemonetics Corporation / Z-1298-2022

Z-1298-2022 Class II Terminated

Recalled by Haemonetics Corporation — Boston, MA

Recall Details

Product Type
Devices
Report Date
July 6, 2022
Initiation Date
April 19, 2022
Termination Date
March 27, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
111

Product Description

Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

Reason for Recall

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.

Distribution Pattern

US Nationwide.

Code Information

This correction is applicable when TEG 5000 PlateletMapping (Item # 07-014, 07-015, 07-016) is performed on a TEG 5000 analyzer (Item # 07-022, 07-033) that is connected to TEG Manager Software which includes viewing of TEG 5000 results. Code Info: UDI-DI: (01)30812747018184 Software Version: TEGM 1.1 and later, TAS v4.2.3

Other recalls by Haemonetics Corporation

  • Z-1310-2022 Class II — TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 (April 26, 2022)
  • Z-1617-2020 Class II — TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0 (February 19, 2020)
  • Z-0905-2020 Class II — Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory component (October 21, 2019)
  • Z-0888-2020 Class II — CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its r (October 21, 2019)
  • Z-0893-2020 Class II — CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its rela (October 21, 2019)
  • Z-0885-2020 Class II — CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its r (October 21, 2019)
  • Z-0906-2020 Class II — Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory component (October 21, 2019)
  • Z-0899-2020 Class II — JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory component (October 21, 2019)
  • Z-0901-2020 Class II — Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory (October 21, 2019)
  • Z-0889-2020 Class II — CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its rel (October 21, 2019)