Microscan Microstrep Plus Panel, 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

K062773 ↗

FDA Product Code

LTT

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class I

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See all devices from Dade Behring, Inc. →