BD PhoenixSpec Nephelometer, Catalog #440910.
FDA Recall Z-0443-06 · Posted 2006-01-25
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJQX
Date Initiated2006-01-17
Date Terminated2006-05-05
Product Quantity488 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.