Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RTH8 Rotor Recalled by Iris Diagnostics Due to Iris International is recalling the RTH8 Rotor used...
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 Iris Diagnostics directly.
Affected Products
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
Quantity: 3912 units
Why Was This Recalled?
Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Iris Diagnostics
Iris Diagnostics has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report