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Terminated

PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.

FDA Recall Z-2111-2013 · 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.

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