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Recall Observatory FDA recall evidence

Device product

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

Z-1310-2022

April 26, 2022

Class II

Product summary

Firm
Haemonetics Corporation
Event
Event 90323
Status
Terminated
Classification
Class II
Quantity
3933 kits (US); 2429 kits (OUS)
Official record key
device-enforcement:Z-1310-2022

Official wording

Reason: 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.

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

Distribution pattern: Domestic distribution US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.