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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Recall Number Z-2112-2013
Classification Class II
Code Info Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
Product Distributed Qty 890 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.

Event Detail

Event Id 65779
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Co.
City Sparks
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.