Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive

• 2 recalls, same reason

  • Terminated Z-1657-2012 FDA Not yet classified ·initiated 10 Apr 2012
  • Terminated Z-1658-2012 FDA Not yet classified ·initiated 10 Apr 2012

  BD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.

510(k) Number

K030677 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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