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U.S. Department of Health and Human Services

Class 3 Device Recall BD FocalPoint"

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  Class 3 Device Recall BD FocalPoint" see related information
Date Initiated by Firm October 06, 2011
Date Posted May 21, 2012
Recall Status1 Terminated 3 on December 03, 2012
Recall Number Z-1629-2012
Recall Event ID 61444
PMA Number P970009 
Product Classification Processor, cervical cytology slide, automated - Product Code MKQ
Product BD Focal Point"100V, Catalog number: 490650

The BD Focal Point" Slide Profiler (formerly the AutoPap¿¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
Code Information To be obtained
Recalling Firm/
Manufacturer		 Tripath Imaging, Inc.
780 Plantation Dr
Burlington NC 27215-6723
For Additional Information Contact Elizabeth Gaipa
919-222-9707
Manufacturer Reason
for Recall		 The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached.
FDA Determined
Cause 2		 Component change control
Action BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit. For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions. For questions regarding this recall call 918-563-1624.
Quantity in Commerce 71 units
Distribution Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
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.
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