Recall Z-1367-2013
Separation Technology, Inc. · initiated March 13, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
Codes / lots: 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.
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1367-2013
- Initiated
- March 13, 2013
- Posted by FDA
- May 23, 2013
- Terminated
- December 24, 2013
- Product code
- IFB – Cytocentrifuge
- Quantity
- 102
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.
- Recalling firm
- Separation Technology, Inc., Sanford, FL