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Recall Observatory FDA recall evidence

Device 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

Z-0198-2018

June 01, 2017

Class III

Product summary

Firm
Becton Dickinson & Co.
Event
Event 78102
Status
Terminated
Classification
Class III
Quantity
7 units
Official record key
device-enforcement:Z-0198-2018

Official wording

Reason: Potential unexpected movement of robot arm

Code information: Serial Numbers: AP0447, AP0448, AP0449, AP0450, AP0451, AP0458 & AP0463.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential unexpected movement of robot arm