Reported Oct 7, 2020 · Terminated
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip…
Ameditech Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ameditech Inc · 9940 Mesa Rim Rd · San Diego, CA · 92121-2910
Is this the product you have?
- Alere iScreen Single Drug Detection (AMT
- Item Number/ AMT Description)X11-IS1 BUP-DX/ "Alere iScreen" Dx
- Single Dip Card Single Drug DetectionBuprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx
- Single Dip Card Single Drug DetectionBarbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionOxycodone (OXY)", X11-IS1 BZO-DX / "Alere iScreen" Dx
- Single Dip Card Single Drug Detection
Benzodiazepine (BZO300)"X11-IS1 MET-DX / "Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionMethamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionAmphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionEcstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionMethadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionMorphine (MOP)", X11-IS1 THC-DX/"Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionMarijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionTricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen¿ Dx
- Single Dip Card Single Drug DetectionPhencyclidine (PCP)"
- Lot codes and dates
- ALL Lots Within Expiry
- Amount recalled
- 303,100 units
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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