Recall Z-0198-2018— Becton Dickinson & Co.
Class III · Terminated
Class III FDA medical device recall by Becton Dickinson & Co., initiated 2017-06-01, terminated 2018-05-09. FDA's recall record names no specific 510(k) clearance for this event. 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: Potential unexpected movement of robot arm.
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-06-01
- Terminated
- 2018-05-09
- Firm location
- Sparks, MD, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.