Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

• 3 recalls, same reason

  • Terminated Z-0935-2019 FDA Class II ·initiated 20 Dec 2018
  • Terminated Z-0934-2019 FDA Class II ·initiated 20 Dec 2018
  • Terminated Z-0933-2019 FDA Class II ·initiated 20 Dec 2018

  Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

510(k) Number

K050745 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive

  Class II

  FDA 510(k) K030677 Active Cleared 1 Apr 2003

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  Class II

  FDA 510(k) K152870 Active Cleared 27 Oct 2015

• Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/Ml

  Class II

  FDA 510(k) K041572 Active Cleared 12 Aug 2004

• Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay

  Class II

  FDA 510(k) K090827 Active Cleared 27 May 2009

• Bd Pen Needle

  Class II

  FDA 510(k) K051899 Active Cleared 13 Sep 2005

• Bd Phoenix Automated Microbiology System

  Class II

  FDA 510(k) K020322 Active Cleared 27 Mar 2002

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