Recall Z-0857-2015— Iris Diagnostics
Class II · Terminated
Class II FDA medical device recall by Iris Diagnostics, initiated 2014-12-03, terminated 2015-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Iris Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-03
- Terminated
- 2015-11-02
- Firm location
- Chatsworth, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.