Z-1643-2012

BD Focal Point"230V LC (Refurbished), Catalog number: 490681. The BD Focal Point" Slide Profiler (formerly...

Name: Z-1643-2012 BD Focal Point"230V LC (Refurbished), Catalog number: 490681. The BD Focal Point" Slide Profiler (formerly...
Creator: Tripath Imaging, Inc.
Published: 2011-10-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-10-06 / Terminated

FDA source

Tripath Imaging, Inc. began a recall of BD Focal Point"230V LC (Refurbished), Catalog number: 490681. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical... on 2011-10-06. The reason FDA records is "The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1643-2012
Status: Terminated
Initiated: 2011-10-06
Posted: 2012-05-21
Terminated: 2012-12-03
Recalling firm: Becton Dickinson & Co
Product: BD Focal Point"230V LC (Refurbished), Catalog number: 490681. 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.
Product code: MKQ Processor, Cervical Cytology Slide, Automated
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.
FDA 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 in commerce: 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
Product codes and lots: To be obtained

Product code MKQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)