PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
FDA Recall Z-2112-2013 · Posted 2013-08-28
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeMKQ
Date Initiated2013-07-08
Date Terminated2014-05-01
Product Quantity890 instruments
Reason for Recall
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Firm Action
Ex-US BD sites were notified via email and teleconference, and will communicate directly with customer sites in their region as required by local regulation. All US customers were initially contacted via telephone and letters were mailed.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.