Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414

• • Terminated Z-1552-2020 FDA Class II ·initiated 9 Apr 2019

  Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.

• • Terminated Z-0053-2014 FDA Class III ·initiated 23 Sep 2013

  Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.

510(k) Number

K060788 ↗

FDA Product Code

DIF

Device Class

Class I

Regulation

21 CFR Part 862.3280

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 →