Recall Z-2110-2013— Becton Dickinson & Co.
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2013-07-08, terminated 2014-05-01. FDA's recall record names no specific 510(k) clearance for this event. Product: PrepStain AG. For use in the screening and detection of cervical cancer.. Reason: PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-08
- Terminated
- 2014-05-01
- Firm location
- Sparks, MD, United States
Product description
PrepStain AG. For use in the screening and detection of cervical cancer.
Reason for recall
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
Data sourced from openFDA. This site is unofficial and independent of the FDA.