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Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Desc...

FDA Device Recall #Z-0053-2014 — Class III — September 23, 2013

Recall Summary

Recall Number Z-0053-2014
Classification Class III — Low risk
Date Initiated September 23, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alere San Diego, Inc.
Location San Diego, CA
Product Type Devices
Quantity 38

Product Description

Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.

Reason for Recall

Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.

Lot / Code Information

Part Number 94413. Lot Number C2681A.

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.

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