T-Cube® TCUBE-7PCPBRecalls & reported problems

Instant Technologies, Inc. · T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following drugs of abuse and their principal metabolites in human oral fluid at specified cut-off levels for use in employment and insurance testing: AMP, COC, MET, OPI, OXY, PCP, and THC. · Class 2

All models of T-Cube (6)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1589-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Device details

UDI-DI	`00817405020959`
Brand	T-Cube®
Model	TCUBE-7PCPB
Company	Instant Technologies, Inc.
Product code	PVD · Test, Methamphetamine, Employment And Insurance Testing, Exempt
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 10, 2022

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.

Other Test, Methamphetamine, Employment And Insurance Testing, Exempt devices

T-Cube® Tcube-6MB
Instant Technologies, Inc. · Test, Methamphetamine, Employment And Insurance Testing, Exempt
1 report

All Test, Methamphetamine, Employment And Insurance Testing, Exempt devices →

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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