Recall Z-1367-2013 ยท IFB Cytocentrifuge
Separation Technology, Inc.
SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
| Date | May 23, 2013 (initiated Mar 13, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 102 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.