FDA Enforcement
Class II
Terminated
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Recall: Z-0570-2013
·
Reported December 26, 2012
Enforcement
- Recall Number
- Z-0570-2013
- Event ID
- 63737
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2012
- Initiation Date
- November 6, 2012
- Classification Date
- December 19, 2012
- Termination Date
- January 9, 2013
- Address
- BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States
Description
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Reason
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Code Info
Lot number 2053373
Distribution
Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
Quantity
12,250 tests