Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TEG 5000 Functional Fibrinogen Reagent Recalled by Haemonetics Corporation Due to Due to a shift in the citrated blood...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Haemonetics Corporation directly.
Affected Products
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Quantity: 3933 kits (US); 2429 kits (OUS)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Haemonetics Corporation
Haemonetics Corporation has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report