FDA Device recall Z-3029-2020
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Dete…
- FDA Device
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Dete… by Ameditech, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3029-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-18 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ameditech |
| Distribution | US |
Product
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Oxycodone (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 Detection: Methamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Amphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Ecstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Morphine (MOP)", X11-IS1 THC-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Marijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Tricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Phencyclidine (PCP)",
Reason
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.
Identifiers
| code_info | ALL Lots Within Expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3029-2020%22
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