Reported Jul 6, 2022 · Terminated
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Haemonetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Haemonetics Corporation · 125 Summer St · Boston, MA · 02110-1616
Is this the product you have?
TEG 5000 Functional Fibrinogen ReagentItem No. 07-034
- Lot codes and dates
- UDI-DI(01)20812747018095 All lots are affected
- Amount recalled
- 3933 kits (US); 2429 kits (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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