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
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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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