FDA Medical Device Recalls (openFDA)
Tripath Imaging, Inc.: BD Focal Point"120V / 15 FOV (Refurbished), Catalog number: 490398. 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 number
- Z-1637-2012
- Recalling firm
- Tripath Imaging, Inc.
- Product
- BD Focal Point"120V / 15 FOV (Refurbished), Catalog number: 490398. 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.
- Status
- Terminated
- Initiated
- 2011-10-06
- Posted
- 2012-05-21
- Terminated
- 2012-12-03
- Reason
- The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached.
- Root 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
- 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
- Lot, serial or model codes
- To be obtained
- 510(k) numbers
- not on file
- PMA numbers
- ["P970009"]
- Product code
- MKQ
- Firm FEI
- 3008007472
- Firm city
- Burlington
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28