Home / Recalls / Haemonetics Corporation / Z-1310-2022

Z-1310-2022 Class II Terminated

Recalled by Haemonetics Corporation — Boston, MA

Recall Details

Product Type
Devices
Report Date
July 6, 2022
Initiation Date
April 26, 2022
Termination Date
March 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3933 kits (US); 2429 kits (OUS)

Product Description

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

Reason for Recall

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.

Distribution Pattern

Domestic distribution US Nationwide.

Code Information

UDI-DI: (01)20812747018095 All lots are affected.

Other recalls by Haemonetics Corporation

  • Z-1298-2022 Class II — Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07 (April 19, 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)