FDA recall Z-0198-2018

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

Reason for recall

Potential unexpected movement of robot arm

Distribution

Worldwide Distribution - US including CA, NC & TN Internationally: Canada

Key facts

Status

Terminated

Initiation date

2017-06-01

Report date

2017-12-13

Termination date

2018-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0198-2018