Device product
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Z-2112-2013
Product summary
- Event
- Event 65779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 890 instruments
- Official record key
device-enforcement:Z-2112-2013
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 - 799-14000-00 (490100) and 799-14000-00R (490407)
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.