Recall Z-2111-2013— 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 Tecan US-I. 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 Tecan US-I. 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.