Recall Z-1635-2012 ยท MKQ Processor, Cervical Cytology Slide, Automated
Tripath Imaging, Inc.
BD Focal Point"120V / 11 FOV (Refurbished), Catalog number: 490653. 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.
| Date | May 21, 2012 (initiated Oct 6, 2011) |
| Status | Terminated |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.