RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4.
FDA device recall Z-0857-2015 · posted 2014-12-23 · Terminated
Recall details
- Recalling firm
- Iris Diagnostics
- Reason for recall
- 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.
- Action taken
- A customer notification letter dated 12/3/14 was sent to all customers to inform them that 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. The letter informs the customers of the problems identified and the actions to be taken. Beckman Coulter will be managing the logistics of the recall notice. Customers with questions are instructed to contact Customer Technical Support at (800) 854-3633 or via website at http://www.beckmancoulter.com.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JQC
- Quantity affected
- 3912 units
- Distribution
- 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
- Date initiated
- 2014-12-03
- Date posted
- 2014-12-23
- Date terminated
- 2015-11-02
- Location
- Chatsworth, CA
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