FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD PhoenixSpec Nephelometer, Catalog #440910.
- Recall number
- Z-0443-06
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD PhoenixSpec Nephelometer, Catalog #440910.
- Status
- Terminated
- Initiated
- 2006-01-17
- Posted
- 2006-01-25
- Terminated
- 2006-05-05
- Reason
- A operator's manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples.
- Root cause
- Other
- Action
- The recalling firm notified direct accounts by courier and international distributors by e-mail on 01/17/06. The notification advised that the the troubleshooting section in the firm''s nephelometer user''s guide, vers. 2004/12, is incorrect in describing the 'CAL?' message as indicating a default calibration is in use. The recalling firm provided a cautionary sticker in the bulletin and described recommended placement on the device by pictorial. The sticker instructs users not to use the nephelometer if 'CAL?' message appears on the units'' LCD screen.
- Quantity
- 488 units
- Distribution
- The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQX
- 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