NA DOA-21107-19Recalls & reported problems

Alere San Diego, Inc. · Integrated E-Z Split Key® Cup II (AMP1000/COC300/THC50)+(MET1000/OPI2000/PCP25)+(BZO300/BAR300)+MTD300+MDMA500 · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815845020765), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

False Positive Result1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 17, 2018False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING POSITIVE AMP, COC, AND THC RESULTS ON TWO DONORS USING TWO MULTI-DRUG 10 PANEL CUPS. THE DONORS DENIED HAVING DRUGS IN THEIR SYSTEM. TESTING WAS PERFORMED ON AN ALTERNATE LOT OF MULTI-DRUG 10 PANEL CUPS AND PRODUCED NEGATIVE RESULTS. THE POSITIVE RESULTS OCCURRED ON 2 DEVICES OUT OF 4 DEVICES USED. NO LABORATORY CONFIRMATION TESTING WAS PERFORMED AND NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7974963 ↗

Device details

UDI-DI	`10815845020765`
Brand	NA
Model	DOA-21107-19
Catalog no.	4080970099
Company	Alere San Diego, Inc.
Product code	DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 13, 2026

Device type (GMDN): Multiple drugs of abuse IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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