Recalls / —
—#43774
Product
BD PhoenixSpec Nephelometer, Catalog #440910.
- FDA product code
- JQX — Nephelometer, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- All codes
Why it was recalled
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 (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Co.
- Address
- 7 Loveton Cir, Sparks, Maryland 21152-9212
Distribution
- Distribution pattern
- The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide.
Timeline
- Recall initiated
- 2006-01-17
- Posted by FDA
- 2006-01-25
- Terminated
- 2006-05-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #43774. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.