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Haemonetics Corporation Recall 90323

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

Haemonetics Corporation Recall 90323 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1310-2022
Event ID90323
Event DescriptionTEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Product TypeDevices
DistributionDomestic distribution US Nationwide.
Quantity3933 kits (US); 2429 kits (OUS)
Recall ReasonDue 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.
Device Classification20220706
Device Code InfoUDI-DI: (01)20812747018095 All lots are affected.
Center Classification Date20220630
Recall Initiation Date20220426
Recalling FirmHaemonetics Corporation
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