BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649. 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.
Recall
- Recall Number
- Z-1640-2012
- Event Number
- 61444
- Firm
- Tripath Imaging, Inc.
- FEI Number
- 3008007472
- Product Code
- MKQ
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- October 6, 2011
- Posted
- May 21, 2012
- Terminated
- December 3, 2012
- Address
- 780 Plantation Dr, Burlington, NC, 27215-6723
Description
BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649. 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.
The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached.
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.
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
see line 1.