Recall Z-1636-2012
Tripath Imaging, Inc. · initiated October 6, 2011
Product
BD Focal Point"120v / 15 FOV under 5%, Catalog number: 490397. 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.
Codes / lots: To be obtained
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-determined cause: Component change control
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.
Details
- Recall number
- Z-1636-2012
- Initiated
- October 6, 2011
- Posted by FDA
- May 21, 2012
- Terminated
- December 3, 2012
- Product code
- MKQ – Processor, Cervical Cytology Slide, Automated
- 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
- Recalling firm
- Tripath Imaging, Inc., Burlington, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1629-2012 | BD Focal Point"100V, Catalog number: 490650 The BD Focal Point" Slide Profiler (formerly…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1630-2012 | BD Focal Point"100V (Refurbished), Catalog number: 490651 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1631-2012 | BD Focal Point"100V / 15 FOV under 5%, Catalog number: 490364 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1632-2012 | BD Focal Point"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 The BD Focal…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1633-2012 | BD Focal Point"100V LC (Refurbished), Catalog number: 490682 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1634-2012 | BD Focal Point"120V / 11 FOV under 5%, Catalog number: 490652 The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1635-2012 | BD Focal Point"120V / 11 FOV (Refurbished), Catalog number: 490653. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1637-2012 | BD Focal Point"120V / 15 FOV (Refurbished), Catalog number: 490398. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1638-2012 | BD Focal Point"120V LC (Refurbished), Catalog number: 490683. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1639-2012 | BD Focal Point"230V / 11 FOV under 5%, Catalog number: 490648. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1640-2012 | BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1641-2012 | BD Focal Point"230V / 15 FOV under 5%, Catalog number: 490137. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1642-2012 | BD Focal Point"230V / 15 FOV (Refurbished), Catalog number: 490138. The BD Focal Point"…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |
| Z-1643-2012 | BD Focal Point"230V LC (Refurbished), Catalog number: 490681. The BD Focal Point" Slide…The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore… | 10/06/2011Terminated |