Alere Recalls Triage TOX Drug Screen Kits Due to Mislabeled Boxes
Alere San Diego, Inc. is recalling Triage TOX Drug Screen kits because the boxes containing the test devices were mislabeled.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeled boxes) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Alere San Diego, Inc. is recalling the Triage TOX Drug Screen Panel, Model# 94400. The recall involves 45,638 units of the product, which is a fluorescence immunoassay intended 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 in urine.
The recall was initiated because the box containing the test devices was mislabeled. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including in the United States and numerous other countries such as Australia, Canada, Germany, and the United Kingdom. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice and contact the manufacturer for instructions on how to proceed.
The recalled product
- 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…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 45,638
Distribution
Distributed nationwide across the United States.
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