FDA recall Z-1310-2022

Product

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

Domestic distribution US Nationwide.

Key facts

Status

Terminated

Initiation date

2022-04-26

Report date

2022-07-06

Termination date

2024-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1310-2022