CLASS II Device recall · Reported 25 Nov 2015 · FDA Enforcement Report
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC recalled by Ameditech
Ameditech is recalling DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, 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-0309-2016
- 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
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.
Where it was distributed
Worldwide Distribution - US (nationwide) and Internationally to Australia.
Questions about this recall
Why was it recalled?
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Which lots are affected?
141379 144260 150225
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
19 other products · FDA event 72471This product is part of a recall event; the main page for the event is 10-Panel Pipette Drug Screen recalled by Ameditech.
More recalls from Ameditech
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|---|---|---|---|---|---|
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