CLASS II Device recall · Reported 25 Nov 2015 · FDA Enforcement Report
12-Panel Dip Drug Screen with adulterant recalled by Ameditech
Ameditech is recalling 12-Panel Dip Drug Screen with adulterant, distributed nationwide in the US. The recall was initiated on 20 Oct 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0302-2016
- FDA event ID
- 72471
- Recalling firm
- Ameditech, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2015
- FDA classified
- 18 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Oct 2015 | Recall initiated by company | |
| 18 Nov 2015 | Classified by FDA | +29 days |
| 25 Nov 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP 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.
Where it was distributed
Worldwide Distribution - US (nationwide) and Internationally to Australia.
Questions about this recall
Is 12-Panel Dip Drug Screen with adulterant recalled?
Yes. Ameditech recalled 12-Panel Dip Drug Screen with adulterant on 20 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0302-2016.
Why was it recalled?
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Which lots are affected?
144302 150323 150661 151143 151467
Where was it sold?
Worldwide Distribution - US (nationwide) and Internationally to Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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