Oxoid Antimicrobial Susceptibility Discs

• • Terminated Z-0443-2016 FDA Class II ·initiated 6 Nov 2015

  Antibiotic concentration may be insufficient which may result in incorrect test results.

• • Terminated Z-1246-2014 FDA Class II ·initiated 18 Feb 2014

  Some of the discs may not be impregnated with the antibiotic.

• • Terminated Z-0794-2014 FDA Class II ·initiated 9 Apr 2013

  Cartridges may contain individual discs which were not impregnated with antibiotic.

• • Terminated Z-2081-2013 FDA Class III ·initiated 25 Mar 2013

  Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

• • Terminated Z-0528-2014 FDA Class III ·initiated 21 Nov 2012

  Boxes labeled as CIP5 may contain cartridges of AMP5.

• • Terminated Z-0808-2013 FDA Class II ·initiated 21 Aug 2012

  The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

510(k) Number

K860153 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Campylobacter Blood-Free Selective Agar Base

  Class I

  FDA 510(k) K850658 Active Cleared 20 Mar 1985

• Campylobacter Blood-Free Selective Agar Baseq

  Class I

  FDA 510(k) K850832 Active Cleared 29 Mar 1985

• Selenite Cystine Broth Base

  Not classified

  FDA 510(k) K841660 Active Cleared 14 May 1984

• Diagnostic Reagent Set-Rpla

  Class I

  FDA 510(k) K855233 Active Cleared 4 Nov 1986

• Staphylase Test

  Class I

  FDA 510(k) K874303 Active Cleared 6 Nov 1987

• X-Factor Discs

  Class I

  FDA 510(k) K802500 Active Cleared 12 Nov 1980

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