Device product
PrepStain AG. For use in the screening and detection of cervical cancer.
Z-2110-2013
Product summary
- Event
- Event 65779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 890 instruments
- Official record key
device-enforcement:Z-2110-2013
Official wording
Reason: PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Code information: Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R
Distribution pattern: Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Derived failure modes
-
Unknown
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.