Z-0443-06

BD PhoenixSpec Nephelometer, Catalog #440910

Name: Z-0443-06 BD PhoenixSpec Nephelometer, Catalog #440910
Creator: Becton Dickinson & Co.
Published: 2006-01-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2006-01-17 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD PhoenixSpec Nephelometer, Catalog #440910 on 2006-01-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0443-06
Status: Terminated
Initiated: 2006-01-17
Posted: 2006-01-25
Terminated: 2006-05-05
Recalling firm: Becton Dickinson & Co
Product: BD PhoenixSpec Nephelometer, Catalog #440910.
Product code: JQX Nephelometer, For Clinical Use
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 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 in commerce: 488 units
Distribution: The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide.
Product codes and lots: All codes

Product code JQX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)