The Recall Desk
HighFDA (Devices)·Z-1367-2013·Announced 2013-05-29

Separation Technology Recalls SlidePrep Plus Cytology Centrifuges for Unexpected Startup

Separation Technology, Inc. is recalling SlidePrep Plus Cytology Centrifuges manufactured before January 1, 2013, because they may start up unexpectedly when exposed to electrostatic discharge.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (unexpected startup) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Separation Technology, Inc. is recalling SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013. The recall involves 102 units distributed nationwide in the United States, including Pennsylvania, North Carolina, Illinois, Kansas, and Florida, as well as in Canada and Turkey.

The recall is due to a defect where the centrifuges have the potential to start up unexpectedly when encountering an electrostatic discharge. The affected units are identified by specific serial numbers, including 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, and 1212.

Users of these devices should check their serial numbers against the list provided by the manufacturer. If the device is affected, users should contact Separation Technology, Inc. for instructions on how to proceed with the recall.

The recalled product

Product
SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
Affected units
102

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers: 0110
  • 0111
  • 0112
  • 0210
  • 0211
  • 0212
  • 0310
  • 0311
  • 0312
  • 0410
  • 0411
  • 0412
  • 0511
  • 0512
  • 0611
  • 0710
  • 0711
  • 0811
  • 0812
  • 0910

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same hazard · unexpected startup

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