Recall Z-2460-2012— Alere San Diego, Inc.

Name: FDA recall Z-2460-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-12

Class II · Terminated

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2012-07-12, terminated 2013-02-01. It names 2 FDA 510(k) clearances: K060791, K043242. Product: Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the 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, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.. Reason: 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..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-12
Terminated: 2013-02-01
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400Biosite Incorporated·cleared 2006-06-22
K043242 — TRIAGE TOX DRUG SCREENBiosite Incorporated·cleared 2005-02-28

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

Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the 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, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

Reason for recall

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.

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