ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abus...
FDA Device Recall #Z-3042-2020 — Class II — August 18, 2020
Recall Summary
| Recall Number | Z-3042-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 18, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ameditech Inc |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 51,075 units |
Product Description
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO
Reason for Recall
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Distribution Pattern
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Lot / Code Information
ALL Lots Within Expiry
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.