Triage TOX Drug Screen Panel — Class II medical device recall Z-0029-2013
Terminated recall by Alere San Diego, Inc., reported 2012-10-17, distributed nationwide. Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was misl
| Recall number | Z-0029-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2009-05-28 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2012-10-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CO, CZ, DE, ES, FR, GR, GT, HK, ID, IN, IT, KR, LB, MX, NL, NO, RO, SA, TN, TR, TW, UY, ZA |
| Quantity | 45,638 units |
| Reason classes | labeling |
| 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 and 148 more |
| Model numbers | 94400 |
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 for recall
Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0029-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.