Recall Z-0857-2015 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Iris Diagnostics
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.
| Date | Dec 23, 2014 (initiated Dec 3, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 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 Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.