Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1367-2013Class II

SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid...

Separation Technology, Inc. / initiated 2013-03-13 / Terminated / root cause: design

Separation Technology, Inc. began a recall of SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1367-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Separation Technology, Inc.
Product
SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
Product code
IFB Cytocentrifuge
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.
Root cause tag
design
FDA 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 in commerce
102
Distribution
Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.
Product codes and 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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1367-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1367-2013Class IITerminatedVoluntary: Firm initiated