Enforcement Report - Week of October 3, 2012
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Product Detail
| 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. |
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| Recall Number | Z-2460-2012 |
| Classification | Class II |
| Code Info | Lot Codes: K51245RB, W51022RB, W51207RB |
| Product Distributed Qty | 591 kits |
| 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. |
Event Detail
| Event Id | 63091 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Alere San Diego, Inc. |
| City | San Diego |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
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