Z-0198-2018Class III

BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix"...

Name: Z-0198-2018 BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix"...
Creator: Becton Dickinson & Co.
Published: 2017-06-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-06-01 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube... on 2017-06-01. FDA classified it as Class III and gives the reason as "Potential unexpected movement of robot arm". 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-0198-2018
Classification: Class III
Status: Terminated
Initiated: 2017-06-01
Posted: 2017-12-06
Terminated: 2018-05-09
Recalling firm: Becton Dickinson & Co
Product: BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing
Product code: JQX Nephelometer, For Clinical Use
Reason for recall: Potential unexpected movement of robot arm
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD Diagnostic Systems telephoned all customers on June 1, 2017 and sent an Urgent Product Recall letter dated May 31, 2017, and Response Forms to their customers via email. BD recently confirmed a manufacturing issue with the motor that drives movement of the robot arm. The issue may result in the inability of this motor to withstand the lateral forces encountered during normal operations. Should this occur, the instrument will indicate an E20 error-Pipettor step loss during operation and stop functioning. While there is no loss of patient sample, the samples would need to be manually processed until the instrument can be repaired. To limit any disruption in the workload, BD Service will contact customers to schedule the instrument replacement. Customers are advised to complete and return the response form via email to [email protected]. Customers may continue to use the instrument until replacement is performed. Customers with questions may contact BD (Customer/Technical) Support at 1-800-638-8663. For questions regarding this recall call 410-316-4258.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution - US including CA, NC & TN Internationally: Canada
Product codes and lots: Serial Numbers: AP0447, AP0448, AP0449, AP0450, AP0451, AP0458 & AP0463.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0198-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0198-2018	Class III	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06

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)