PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
This recall has been terminated (originally issued August 28, 2013).
- Recall Initiated
- July 8, 2013
- Posted
- August 28, 2013
- Terminated
- May 1, 2014
- Recall Number
- Z-2112-2013
- Quantity
- 890 instruments
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
Lot / Code Info
Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
Root Cause
Software design
Action Taken
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.
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