TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Check against the official notice below — it lists the full affected range.
Haemonetics Corporation is recalling the TEG 5000 Functional Fibrinogen Reagent (Item No. 07-034) due to a shift in the citrated blood reference range for a normal population. The normal reference ranges provided in the product's instructions for use (IFU) are no longer accurate. If clinicians rely solely on test results compared to the stated normal donor reference range, patients could be misdiagnosed or receive incorrect treatment, or necessary treatment could be missed.
The recall affects all lots of this product distributed nationwide in the United States, totaling 3,933 kits, as well as 2,429 kits distributed outside the US. The product is identified by UDI-DI (01)20812747018095. The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 3933 kits (US); 2429 kits (OUS) Lot/code info: UDI-DI: (01)20812747018095 All lots are affected.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.