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U.S. Department of Health and Human Services

Class 2 Device Recall PrepStain Tecan USII

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  Class 2 Device Recall PrepStain Tecan USII see related information
Date Initiated by Firm July 08, 2013
Date Posted August 28, 2013
Recall Status1 Terminated 3 on May 01, 2014
Recall Number Z-2112-2013
Recall Event ID 65779
PMA Number P970018S025 
Product Classification Processor, cervical cytology slide, automated - Product Code MKQ
Product PrepStain Tecan US-II.

For use in the screening and detection of cervical cancer.
Code Information Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4054
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 890 instruments
Distribution Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MKQ and Original Applicant = BD Diagnostic Systems
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