FDA-Device2013-09-04Class II
PrepStain AG. For use in the screening and detection of cervical cancer.
Becton Dickinson & Co.
Hazard
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Sold states
Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Affected count
890 instruments
Manufactured in
BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, United States
Products
PrepStain AG. For use in the screening and detection of cervical cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2110-2013Don't want to check this manually?
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