Z-1367-2013 Class II Terminated
FDA device recall Z-1367-2013 was initiated by Separation Technology, Inc. on March 13, 2013 and is designated Class II. 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 disc… The recall status is terminated (terminated December 24, 2013). Affected quantity: 102.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- March 13, 2013
- Termination Date
- December 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102
Product Description
SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.
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.