FDAFDA · Food and drugs·Recall number Z-0857-2015
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.
Published December 31, 2014 · Recall initiated: December 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Iris Diagnostics
- Distributor
- Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.
- Lot
- Serial No. 3100 through 7012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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