Microscan Microstrep Plus Panel Ampicillin (0.013 - 16 Mcg/Ml)

• 2 recalls, same reason

  • Terminated Z-0108-2016 FDA Class II ·initiated 10 Sep 2015 ·via K062927, on the same 510(k)
  • Terminated Z-0109-2016 FDA Class II ·initiated 10 Sep 2015 ·via K062927, on the same 510(k)

  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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K062927 ↗

FDA Product Code

LRG

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Dade Behring, Inc. →