Triage Total Controls 5, Triage Total Calibration Verification 5

• • Terminated Z-3054-2020 FDA Class II ·initiated 28 Jul 2020

  Product was shipped with refrigeration (ice) instead of frozen (dry ice).

• • Terminated Z-0588-2017 FDA Class II ·initiated 12 Oct 2016

  Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

• 3 recalls, same reason

  • Terminated Z-1790-2010 FDA Unclassified (pre-2012) ·initiated 6 Feb 2009
  • Terminated Z-1788-2010 FDA Unclassified (pre-2012) ·initiated 6 Feb 2009
  • Terminated Z-1789-2010 FDA Unclassified (pre-2012) ·initiated 6 Feb 2009

  Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.

510(k) Number

K072892 ↗

FDA Product Code

JJY

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

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 →