BD Phoenix AP Instrument Recalled for Potential Robot Arm Movement
Becton Dickinson & Co. is recalling seven BD Phoenix AP instruments due to a potential for unexpected robot arm movement.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classifies this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the criteria for a Low severity score.
Plain-English summary
Becton Dickinson & Co. is recalling seven units of the BD Phoenix AP instrument, Catalog Number 448010. The recall is issued because of a potential for unexpected movement of the robot arm. The affected units have serial numbers AP0447, AP0448, AP0449, AP0450, AP0451, AP0458, and AP0463.
The BD Phoenix AP instrument is designed to standardize ID broth tube inoculum, add AST indicator to AST broth tubes, and transfer aliquots of ID broth to AST broth tubes for the BD Phoenix system. The agency classifies this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The affected units were distributed worldwide, including in the United States (California, North Carolina, and Tennessee) and Canada. Users should contact Becton Dickinson & Co. for instructions on how to address the issue.
The recalled product
- 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…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Serial Numbers: AP0447
- AP0448
- AP0449
- AP0450
- AP0451
- AP0458 & AP0463.
Distribution
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