FDAFDA · Food and drugs·Recall number Z-2111-2013
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
Published September 4, 2013 · Recall initiated: July 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
- Lot
- Catalog Numbers - 799-13000-00 and 799-13000-00R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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