CLASS II Device recall · Reported 7 Oct 2020 · FDA Enforcement Report
Oratect III Oral Fluid Drug Screen Device (AMT recalled by Ameditech
Ameditech is recalling Oratect III Oral Fluid Drug Screen Device (AMT, distributed nationwide in the US. The recall was initiated on 18 Aug 2020 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-3041-2020
- FDA event ID
- 86335
- Recalling firm
- Ameditech, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Aug 2020
- FDA classified
- 30 Sep 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Aug 2020 | Recall initiated by company | |
| 30 Sep 2020 | Classified by FDA | +43 days |
| 7 Oct 2020 | 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
XXX
Product as listed by the FDA
Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "
Where it was distributed
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Questions about this recall
Why was it recalled?
XXX
Which lots are affected?
ALL Lots Within Expiry
Where was it sold?
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
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
22 other products · FDA event 86335This product is part of a recall event; the main page for the event is First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC) recalled.
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