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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 17, 2006
Date Posted January 25, 2006
Recall Status1 Terminated 3 on May 05, 2006
Recall Number Z-0443-06
Recall Event ID 34396
Product Classification Nephelometer, For Clinical Use - Product Code JQX
Product BD¿ PhoenixSpec¿ Nephelometer, Catalog #440910.
Code Information All codes
Recalling Firm/
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact BD Technical Services
800-638-8663 Ext. 2
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 488 units
Distribution The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.