CT0006B

• FDA 510(k) K860153 decided 4 Mar 1986 Active
• FDA GUDID UDI-DI 05032384005536 listed 24 Sep 2016 Listed

• • 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.

1. 4 Mar 1986 Cleared FDA 510(k) K860153
2. 21 Aug 2012 Recall initiated FDA recalls Z-0808-2013
3. 21 Nov 2012 Recall initiated FDA recalls Z-0528-2014
4. 25 Mar 2013 Recall initiated FDA recalls Z-2081-2013
5. 9 Apr 2013 Recall initiated FDA recalls Z-0794-2014
6. 18 Feb 2014 Recall initiated FDA recalls Z-1246-2014
7. 6 Nov 2015 Recall initiated FDA recalls Z-0443-2016
8. 24 Sep 2016 Listed FDA GUDID 05032384005536

Generic name

Carbenicillin susceptibility testing disc IVD

Model / reference

CT0006B

Primary DI / UDI-DI

05032384005536

510(k) Number

K860153 ↗

FDA product code

JTN

GMDN term

Carbenicillin susceptibility testing disc IVD

Device class

Class II

Regulation number

866.1620

GUDID distribution status

In Commercial Distribution

Category: Carbenicillin susceptibility testing disc IVD

Other devices filed under FDA product code JTN (Susceptibility Test Discs, Antimicrobial).

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• IFA SENSIBAC TETRACYCLINE by Investigacion Farmaceutica S.A. DE C.V.
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• Modification of Pasco MIC and MIC/ID Panels by Pasco Laboratories, Inc.
• Augmentin 30MCG Suscep Disk by Warner-Lambert Co.
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• Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10 CT1975B

  Class II

  FDA 510(k) K251337 Active Cleared 5 Dec 2025 GUDID on market

• Microbact Gnb 24E Tray (40 Id's) MB1131A

  Class I

  CE/IVDD GUDID on market

• CT0794B

  Class II

  CE/IVDD FDA 510(k) K984608 Active Cleared 9 Mar 1999 +1authorizations

• Microbact Program for Windows MB1244A

  Class I

  CE/IVDD GUDID on market

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