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U.S. Department of Health and Human Services

Class 2 Device Recall RTH8 Rotor

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  Class 2 Device Recall RTH8 Rotor see related information
Date Initiated by Firm December 03, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on November 02, 2015
Recall Number Z-0857-2015
Recall Event ID 69946
Product Classification Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
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.
Code Information Serial No. 3100 through 7012
Recalling Firm/
Manufacturer		 Iris Diagnostics
9172 Eton Ave
Chatsworth CA 91311-5805
For Additional Information Contact
818-709-1244
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action A customer notification letter dated 12/3/14 was sent to all customers to inform them that 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 letter informs the customers of the problems identified and the actions to be taken. Beckman Coulter will be managing the logistics of the recall notice. Customers with questions are instructed to contact Customer Technical Support at (800) 854-3633 or via website at http://www.beckmancoulter.com.
Quantity in Commerce 3912 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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