Iris Diagnostics Recalls RTH8 Rotor for StatSpin Express 4 Centrifuge
Iris Diagnostics is recalling RTH8 rotors for the StatSpin Express 4 Horizontal Centrifuge because the parts may develop cracks with use over time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (a centrifuge rotor that may crack) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Iris Diagnostics is recalling the RTH8 Rotor, part number X01-005847-001, which is used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The recall affects 3,912 units with serial numbers ranging from 3100 through 7012.
The recall is being issued because the RTH8 rotor may develop cracks with use over time. The StatSpin Express 4 Centrifuge is intended for in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
The affected products were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations such as Australia, Canada, China, Germany, Japan, and the United Kingdom. Users should stop using the affected rotors and contact Iris Diagnostics for further instructions.
The recalled product
- 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…
- Manufacturer
- Iris Diagnostics
- Hazard
- Affected units
- 3,912
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial No. 3100 through 7012
Distribution
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