Z-0198-2018 Class III Terminated
FDA device recall Z-0198-2018 was initiated by Becton Dickinson & Co. on June 1, 2017 and is designated Class III. Reason for recall: Potential unexpected movement of robot arm The recall status is terminated (terminated May 9, 2018). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- June 1, 2017
- Termination Date
- May 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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
Distribution Pattern
Worldwide Distribution - US including CA, NC & TN Internationally: Canada
Code Information
Serial Numbers: AP0447, AP0448, AP0449, AP0450, AP0451, AP0458 & AP0463.