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Z-0857-2015 Class II Terminated

Recalled by Iris Diagnostics — Chatsworth, CA

FDA device recall Z-0857-2015 was initiated by Iris Diagnostics on December 3, 2014 and is designated Class II. 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. The recall status is terminated (terminated November 2, 2015). Affected quantity: 3912 units.

Recall Details

Product Type: Devices
Report Date: December 31, 2014
Initiation Date: December 3, 2014
Termination Date: November 2, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3912 units

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.

Distribution Pattern

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, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.

Code Information

Serial No. 3100 through 7012