BD Focal Point"120V / 11 FOV under 5%, Catalog number: 490652 The BD Focal Point" Slide Profiler (formerly the AutoPap S

FDA device recall Z-1634-2012 · posted 2012-05-21 · Terminated

Recall details

Recalling firm

Tripath Imaging, Inc.

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.

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.

Root cause

Component change control

Status

Terminated

Product code

MKQ

Quantity affected

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

Date initiated

2011-10-06

Date posted

2012-05-21

Date terminated

2012-12-03

Location

Burlington, NC