FDAFDA · Food and drugs·Recall number Z-0570-2013
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.
Published December 26, 2012 · Recall initiated: November 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
- Lot
- Lot number 2053373
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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