PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
FDA device recall Z-2111-2013 · posted 2013-08-28 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKQ
- Quantity affected
- 890 instruments
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
- Date initiated
- 2013-07-08
- Date posted
- 2013-08-28
- Date terminated
- 2014-05-01
- Location
- Sparks, MD
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