BD PhoenixSpec Nephelometer, Catalog #440910.
FDA device recall Z-0443-06 · posted 2006-01-25 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQX
- Quantity affected
- 488 units
- Distribution
- The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide.
- Date initiated
- 2006-01-17
- Date posted
- 2006-01-25
- Date terminated
- 2006-05-05
- Location
- Sparks, MD
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