Z-3029-2020Class II

Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx...

Name: Z-3029-2020 Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx...
Creator: Ameditech Inc
Published: 2020-08-18
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2020-08-18 / Terminated / root cause: manufacturing process

FDA source

Ameditech Inc began a recall of Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine... on 2020-08-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3029-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-18
Posted: 2020-09-30
Terminated: 2024-09-30
Recalling firm: Ameditech, Inc.
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)",
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A Field Corrective Action Notice letter was sent to affected consignees. The Customer notifications commenced on 19-Aug-2020. The consignees are requested to return all non-expired product in their possession to the recalling firm. Method of Notification, 1st contact: Written field corrective action notification letters will be sent via certified mail with delivery tracking to each consignee along with a pre-paid return label to return any product remaining in stock. 2nd & 3rd contact: Telephone, follow up email, or written mail communication will be used as necessary.
Quantity in commerce: 303,100 units
Distribution: US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Product codes and lots: ALL Lots Within Expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3029-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3029-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3030-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3031-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3032-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3033-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3034-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3035-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3036-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3037-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3038-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3039-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3040-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3041-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3042-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3043-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3044-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3045-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3046-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3047-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3048-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3049-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3050-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30
Z-3051-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30

Product code DIO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)