Accuprobe Mycobacterium Avium Complex Culture

• • Terminated Z-1437-2011 FDA Unclassified (pre-2012) ·initiated 30 Dec 2008

  This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.

510(k) Number

K921435 ↗

FDA Product Code

LQF

FDA applicant

Gen-Probe, Inc.

Device Class

Class I

Regulation

21 CFR Part 866.3370

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Pace 2 System for Chlamydia Trachomatis

  Class I

  FDA 510(k) K920378 Active Cleared 29 Apr 1992

• Accuprobe Mycobacterium Tuberculosis Complex Test

  Class I

  FDA 510(k) K896493 Active Cleared 11 Apr 1990

• Accuprobe Mycobacterium Gordonae Culture Test

  Class I

  FDA 510(k) K896492 Active Cleared 16 Apr 1990

• Gen-Probe Aptima Assay for Neisseria Gonorrhoeae

  Class II

  FDA 510(k) K043144 Active Cleared 14 Mar 2005

• Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199

  Class I

  FDA 510(k) K063451 Active Cleared 22 Jan 2007

• Tigris Dts Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196

  Class II

  FDA 510(k) K061509 Active Cleared 4 Oct 2006

See all devices from Gen-Probe →