Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Haemonetics TEG Hemostasis System Level II Control Recalled by Haemonetics Corporation Due to Specific lots of Level II Control Kits produce...
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
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
Quantity: 4,143 kits
Why Was This Recalled?
Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
Where Was This Sold?
Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
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