Class 3 Device Recall BD FocalPoint"

• Date Initiated by Firm: October 06, 2011
• Date Posted: May 21, 2012
• Recall Status: Terminated on December 03, 2012
• Recall Number: Z-1630-2012
• Recall Event ID: 61444
• PMA Number: P970009
• Product Classification: Processor, cervical cytology slide, automated - Product Code MKQ
• Product: BD Focal Point"100V (Refurbished), Catalog number: 490651 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: 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: see line 1.
• 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.