DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Te...

FDA Device Recall #Z-0309-2016 — Class II — October 20, 2015

Recall Summary

Recall Number Z-0309-2016
Classification Class II — Moderate risk
Date Initiated October 20, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ameditech Inc
Location San Diego, CA
Product Type Devices
Quantity 160 units

Product Description

DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Reason for Recall

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia.

Lot / Code Information

141379 144260 150225

Other Recalls from Ameditech Inc

Recall # Classification Product Date
Z-3051-2020 Class II Drug Screening Component: Uncut Sheets Part Nu... Aug 18, 2020
Z-3032-2020 Class II CLIA Waived Rapid Drug Test (AMT Item Number/ ... Aug 18, 2020
Z-3044-2020 Class II TDDA Drugs of Abuse Cup(AMT Item/ AMT Descripti... Aug 18, 2020
Z-3036-2020 Class II ImmuTest Drugs of Abuse Cup (AMT Item Number/ A... Aug 18, 2020
Z-3039-2020 Class II Noble 1 Step+ Cup (AMT Item Number/ AMT Descrip... Aug 18, 2020

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.