Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSC...

FDA Device Recall #Z-0315-2016 — Class II — October 20, 2015

Recall Summary

Recall Number Z-0315-2016
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 31,530 units

Product Description

ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; 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

134545 150270 150542 134346 134347 141739 141836 141841 142565 142951 143151 143875 144102 144106 144239 144241 144362 150192 150198 150629 150630 150651 150791 150959 151037 151358 151359 143402 143813 144240 151395 134181 141028 141458 142039 142111 142385 142396 142498 142717 142823 142957 142972 143514 143828 144298 144301 144308 144309 144310 144519 144520 144540 144541 150087 150108 150145 150169 150514 150516 150639 150810 151018 151523 151524 143574 143947 145055 150037 150187 150310 150457 150660 150881 150941 151465 151468 142864 150051 150512 141889 144364 150792 141747 142054 144104 144363 150689 151066 151067 142284 150208 150509 150643 150936 140904 141374 141527 141746 144261 144537 151282 151295 144336 150879 G150042 G140426 G150017 G150048 G150069 G150111 G150146 140905 140906 141014 141027 141225 141228 141347 141440 141446 141510 141740 141742 141751 144334 144335 144539 144545 144546 150148 150154 150168 150232 150462 150478 150601 150602 150653 150808 150938 151283 142514 143150 143404 143858 144394 144440 150482 150513 150904 151372 142528 143154 143405 150339 151297 150050 142529 142971 143155 143474 144547 150286 150654 150786 143803 150003 150207 150828 143874 144562 150182 150231 150325 141296 141372 141475 141476 141583 141842 143825 144227

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.

More from Ameditech Inc Recalls by Firm Recall Reasons Device Safety Stats