Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluore...
FDA Device Recall #Z-2460-2012 — Class II — July 12, 2012
Recall Summary
| Recall Number | Z-2460-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 12, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alere San Diego, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 591 kits |
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.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
Lot Codes: K51245RB, W51022RB, W51207RB
Other Recalls from Alere San Diego, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1702-2024 | Class II | Abbott Cholestech LDX Battery Kit, Model: 3LP65... | Mar 1, 2024 |
| Z-1508-2022 | Class II | The Cholestech LDX¿ System combines enzymatic m... | Jun 24, 2022 |
| Z-2475-2019 | Class II | Alere Cholestech LDX Analyzer, model # 14-874 c... | Feb 15, 2019 |
| Z-0418-2018 | Class II | Triage Drugs of Abuse Plus TCA 25 Test Kit, Mod... | Nov 14, 2017 |
| Z-0588-2017 | Class II | Alere Triage Total 5 Control Level 1, Model No.... | Oct 12, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.