Bd Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test

• • Terminated Z-0171-2018 FDA Class II ·initiated 11 May 2017

  BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. As the product should not be used when quality control (QC) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform QC testing and uses the panel, there is a potential to incorrectly treat a Staphylococcus infection with clindamycin based on the iMLSb test result. This issue can be detected 100% of the time when used per package insert instructions with iMLSb positive strain S. aureus BAA-977.

510(k) Number

K082538 ↗

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

• BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit

  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, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

  FDA 510(k) K050745 Active Cleared 29 Apr 2005

See all devices from Becton, Dickinson & Co. →