Z-0430-06

BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit...

Name: Z-0430-06 BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit...
Creator: Becton Dickinson & Co.
Published: 2005-12-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2005-12-01 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and labeled in part ***Becton, Dickinson and... on 2005-12-01. The reason FDA records is "A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0430-06
Status: Terminated
Initiated: 2005-12-01
Posted: 2006-01-24
Terminated: 2006-04-06
Recalling firm: Becton Dickinson & Co
Product: BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA***
Product code: JQX Nephelometer, For Clinical Use
Reason for recall: A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The recalling firm notified consignees by phone, fax and e-mail on 12/01/05. The notification advised that nephelometers displaying 'CAL' error messages on the LED should not be used until calibrated with a different kit lot. Consignees were requested to discard referenced lots for replacement. A response form was included in the notification.
Quantity in commerce: 145 kits
Distribution: Product was sold to direct accounts nationwide and international affiliated distributors in Japan, Belize, Taiwan, Canada, Korea, Australia, and the Philippines.
Product codes and lots: Lot 5075281 Exp 2/14/06*** Lot 5115146 Exp 2/14/06

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)