BD Focal Point"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 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.
This recall has been terminated (originally issued May 21, 2012).
- Company
- Tripath Imaging, Inc.
- Recall Initiated
- October 6, 2011
- Posted
- May 21, 2012
- Terminated
- December 3, 2012
- Recall Number
- Z-1632-2012
- Quantity
- see line 1.
- Firm Location
- Burlington, NC
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
To be obtained
Root Cause
Component change control
Action Taken
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.