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Recall Observatory FDA recall evidence

Device product

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

Z-1367-2013

March 13, 2013

Class II

Product summary

Firm
Separation Technology, Inc.
Event
Event 64718
Status
Terminated
Classification
Class II
Quantity
102
Official record key
device-enforcement:Z-1367-2013

Official wording

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.

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.

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.