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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer. Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407) Class II PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. 890 instruments Z-2112-2013
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer. Catalog Numbers - 799-13000-00 and 799-13000-00R Class II PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. 890 instruments Z-2111-2013
PrepStain AG. For use in the screening and detection of cervical cancer. Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R Class II PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. 890 instruments Z-2110-2013
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