Alere San Diego, Inc. 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 t Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 t
Brand
Alere San Diego, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: W42932B W42933B W42934B W42935B W43279B W43281B W43282B W43283B W43284B W43285B W43286B W43287B W43288B W43637B W43638B W43640B W43646B W43648B W43649B W43650B W43652B W43653B W43655B W43657B W43659B W43660B W43661B W43663B W43664B W43665B W43692B W43693B W43694B W43695B W43696B W43697B W43698B W43699B W43700B W43701B W43702B W43703B W43704B W43705B W43706B W43707B W43708B W43709B W43710B W43711B W43712B W43713B W43714B W43715B W43716B W43717B W43718B W43983B W43984B W43985B W43986B W43987B W43988B W43989B W43990B W43991B W43992B W43993B W43994B W43995B W43996B W43997B W43998B W43999B W44000B W44001B W44002B W44003B W44004B W44005B W44006B W44007B W44008B W44009B W44010B W44011B W44012B W44013B W44014B W44015B W44016B W44017B W44018B W44019B W44020B W44021B W44022B W44023B W44024B W44025B W44026B W44027B W44028B W44029B W44030B W44031B W44032B W44033B W44034B W44036B W44037B W44038B W44039B W44040B W44041B W44042B W44043B W44044B W44045B W44046B W44047B W44048B W44049B W44050B W44051B W44052B W44053B W44054B W44055B W44056B W44057B W44058B W44059B W44060B W44061B W44062B W44063B W44064B W44065B W44066B W44067B W44068B W44246B W44269B W44628B W44665B W44666B W44667B W44668B W44669B W44670B W44671B W44672B W44673B W44675B W44676B W44677B W44678B W44679B W44680B W44681B W44682B W44683B W44684B W44686B W44687B W44688B W44690B W44692B W44693B W44697B W44698B W44699B W44700B W44703B W44704B W44708B W44709B W44710B W44712B W44713B W44715B W44716B W44717B W44718B W44719B W44723B W44988B
Alere San Diego, Inc. is recalling Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a flu due to Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026