PlainRecalls
FDA Devices Moderate 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.

Reported: December 26, 2012 Initiated: November 6, 2012 #Z-0570-2013

Product 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 for Recall

An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
12,250 tests
Distribution
Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
Location
Sparks, MD

Frequently Asked Questions

What product was recalled?
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.. Recalled by Becton Dickinson & Co.. Units affected: 12,250 tests.
Why was this product recalled?
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0570-2013.