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U.S. Department of Health and Human Services

Class 2 Device Recall SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE

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  Class 2 Device Recall SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE see related information
Date Initiated by Firm March 13, 2013
Date Posted May 23, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1367-2013
Recall Event ID 64718
Product Classification Cytocentrifuge - Product Code IFB
Product SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE.

Produce a monolayer of cells onto a glass slide from any fluid suspension.
Code Information Serial numbers: 0110, 0111, 0112, 0210, 0211, 0212, 0310, 0311, 0312, 0410, 0411, 0412, 0511, 0512, 0611, 0710, 0711, 0811, 0812, 0910, 0911, 0912, 1011, 1012, 1112, 1210, 1212.
Recalling Firm/
Manufacturer		 Separation Technology, Inc.
582 Monroe Rd Ste 1424
Sanford FL 32771-8821
For Additional Information Contact Jeff Fowler
407-788-8791
Manufacturer Reason
for Recall		 Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.
FDA Determined
Cause 2		 Device Design
Action On March 13, 2013, Separation Technology, Inc. sent their customers letters instructing them to complete and return the attached Acknowledgement & Receipt form via fax to (407) 788-3677 and requesting the return of the SlidePrep Plus Cytology Centrifuges to STI for correction. For any questions regarding this recall, call STI Customer Service at (800) 777-6668.
Quantity in Commerce 102
Distribution Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.
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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