The Recall Desk
HighFDA (Devices)·Z-0857-2015·Announced 2014-12-31

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.

What this means for you

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 s
Manufacturer
Iris Diagnostics
Category
Medical Device — Laboratory Equipment
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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