ProScreen 10 Drug Panel Cassette Test — Class II medical device recall Z-0315-2016
Terminated recall by Ameditech Inc, reported 2015-11-25, distributed nationwide. Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
| Recall number | Z-0315-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ameditech Inc, San Diego, CA, United States |
| Recall initiated | 2015-10-20 |
| Classified | 2015-11-18 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-11-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 31,530 units |
| Model numbers | CPSP-10PPX, PSCUP-10AB, PSCUP-10M, PSCUP-10MMO-300, PSCUP-6BO-W, PSCUP-6MB-W, PSCUP-8P-W, PSCUPA-10AM, PSCUPA-10MO, PSCUPA-12M, PSCUPA-12PP, PSCUPA-12TBU, PSCUPA-6MB-W, PSCUPA-6MBAU, PSD-10APO-300, PSD-10CMO3, PSD-10M, PSD-10MMO-300, PSD-10MOX, PSD-11MT, PSD-12BUP, PSD-5MB, PSD-6BUPO, PSD-6MB, PSD-6MBO and 10 more |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.