Triage Tox Drug Screen

• • Terminated Z-2460-2012 FDA Class II ·initiated 12 Jul 2012

  Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.

510(k) Number

K043242 ↗

FDA Product Code

LDP

Device Class

Class II

Regulation

21 CFR Part 862.3030

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Biosite Triage Panel For Drugs Of Abuse (50NG/ML)

  Class II

  FDA 510(k) K931598 Active Cleared 12 May 1993

• Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I

  Class II

  FDA 510(k) K973126 Active Cleared 6 Oct 1997

• Modification to Triage B-Type Natriuretic Peptide (Bnp) Test

  Class II

  FDA 510(k) K032235 Active Cleared 28 Jan 2004

• One Step Eddp (Methadone Metabolite) Test Strip

  Class II

  FDA 510(k) K092048 Active Cleared 19 Apr 2010

• Biosite Diagnostics Opiate Screening Test

  Class II

  FDA 510(k) K902924 Active Cleared 14 Sep 1990

• Triage Tox Drug Screen, Catalog #94000

  Class II

  FDA 510(k) K012745 Active Cleared 10 Jan 2002

See all devices from Biosite Incorporated →