FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
- Recall number
- Z-2112-2013
- Recalling firm
- Becton Dickinson & Co.
- Product
- PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
- Status
- Terminated
- Initiated
- 2013-07-08
- Posted
- 2013-08-28
- Terminated
- 2014-05-01
- 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.
- Lot, serial or model codes
- Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)
- 510(k) numbers
- not on file
- PMA numbers
- ["P970018S025"]
- Product code
- MKQ
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28