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U.S. Department of Health and Human Services

Class 2 Device Recall StatSpin Centrifuge

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  Class 2 Device Recall StatSpin Centrifuge see related information
Date Initiated by Firm September 29, 2006
Date Posted November 21, 2006
Recall Status1 Terminated 3 on December 13, 2006
Recall Number Z-0198-2007
Recall Event ID 36459
Product Classification Centrifuge - Product Code JQC
Product StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502
Code Information Rotors with serial numbers: B1562 to B1738
Recalling Firm/
Manufacturer		 Iris Sample Processing
60 Glacier Drive
Westwood MA 02090-1825
For Additional Information Contact Louis Fallocne
781-551-0100 Ext. 6113
Manufacturer Reason
for Recall		 Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.
FDA Determined
Cause 2		 Other
Action Iris telephoned customers on 9/29/06 and advised them of the recall of the rotor. New rotors were mailed Overnight Confirmed Delivery with instructions for replacement and return of the the old rotor.
Quantity in Commerce 94 units (Revised on 11/15/06 to 116 units)
Distribution Nationwide
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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