SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1367-2013 | Class II | Terminated | Voluntary: Firm initiated |
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