Recall Z-0029-2013— Alere San Diego, Inc.

Name: FDA recall Z-0029-2013
Creator: U.S. Food and Drug Administration
Published: 2009-05-28

Class II · Terminated

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2009-05-28, terminated 2012-10-10. It names one FDA 510(k) clearance: K060791. Product: Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.. Reason: Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Terminated
Initiated: 2009-05-28
Terminated: 2012-10-10
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400Biosite Incorporated·cleared 2006-06-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.

Reason for recall

Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.