Recall Z-2111-2013 ยท MKQ Processor, Cervical Cytology Slide, Automated
Becton Dickinson & Co.
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
| Date | Aug 28, 2013 (initiated Jul 8, 2013) |
| Status | Terminated |
| Reason | PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. |
| Root cause | Software design |
| Action | Ex-US BD sites were notified via email and teleconference, and will communicate directly with customer sites in their region as required by local regulation. All US customers were initially contacted via telephone and letters were mailed. |
| Quantity | 890 instruments |
| Distribution | Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.