Haemonetics Corporation: Medical Device Recall in 2022 - (Recall #: Z-1310-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 26, 2022

Date Posted: July 6, 2022

Recall Number: Z-1310-2022

Event ID: 90323

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.

Status: Terminated

Product Quantity: 3933 kits (US); 2429 kits (OUS)

Code Information:

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

Distribution Pattern:

Domestic distribution US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated