Reported Dec 31, 2014 · Terminated
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No.…
Iris Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iris Diagnostics · 9172 Eton Ave · Chatsworth, CA · 91311-5805
Is this the product you have?
- 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 CentrifugeFor in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes
- Lot codes and dates
- Serial No. 3100 through 7012
- Amount recalled
- 3912 units
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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