FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: Becton Dickinson's ProbeTec (tm) ET Instrument
- Recall number
- Z-1094-03
- Recalling firm
- Becton Dickinson & Co.
- Product
- Becton Dickinson's ProbeTec (tm) ET Instrument
- Status
- Terminated
- Initiated
- 2003-07-21
- Posted
- 2003-08-20
- Terminated
- 2003-11-19
- Reason
- Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
- Root cause
- Other
- Action
- The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.
- Quantity
- 1015 units
- Distribution
- Product was distributed to domestic and military end users nationwide and international distributors.
- Lot, serial or model codes
- Instrument serial numbers 1001-2056
- 510(k) numbers
- ["K984631"]
- PMA numbers
- not on file
- Product code
- LSL
- 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