Microscan Microstrep Plus Panel New Antimicrobial-Penicillin

• 2 recalls, same reason

  • Terminated Z-0108-2016 FDA Class II ·initiated 10 Sep 2015
  • Terminated Z-0109-2016 FDA Class II ·initiated 10 Sep 2015

  Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

510(k) Number

K020626 ↗

FDA Product Code

LTT

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Microscan Dried Gram-Positive Mic/Combo Panels - Ertapenem

  Class II

  FDA 510(k) K043589 Active Cleared 14 Feb 2005

• MicroScan Dried Gram Negative MIC/Combo Panels, ESBL Screen

  Class II

  FDA 510(k) K981199 Active Cleared 18 Nov 1998

• Streptococcus Mic Panel

  Class II

  FDA 510(k) K963641 Active Cleared 18 Dec 1996

• MicroScan Microstrep Plus Panel New Antimicrobial-Erythromycin

  Class II

  FDA 510(k) K021078 Active Cleared 6 Jun 2002

• MicroScan MicroStrep Plus Panel-Tetracycline

  Class II

  FDA 510(k) K020939 Active Cleared 17 May 2002

• Dried Gram-Negative Gram-Negative MIC/Combo Panels

  Class II

  FDA 510(k) K971376 Active Cleared 30 May 1997

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