Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests

• • Completed Z-0418-2018 FDA Class II ·initiated 14 Nov 2017

  The recalled lots have demonstrated unexpected false positive THC results.

• • Terminated Z-1130-2012 FDA Not yet classified ·initiated 4 Jan 2012 ·on shared 510(k) K973784

  Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.

• • Terminated Z-0521-2012 FDA Unclassified (pre-2012) ·initiated 1 Jul 2011

  The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928.

• • Terminated Z-1088-2009 FDA Unclassified (pre-2012) ·initiated 6 Nov 2008

  The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K973784 ↗

FDA Product Code

DKZ

Device Class

Class II

Regulation

21 CFR Part 862.3100

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 →