T-Cube® Tcube-6MBRecalls & 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, BZO, MET, COC, OPI, THC. · Class 2
Data updated Oct 13, 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 00858945006911), received between Jun 27, 2018 and Jun 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Slipped1
- Fail-Safe Design Failure1
- Nonstandard Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2018Fail-Safe Design Failure; Nonstandard Device; Device Slipped; Fail-Safe Design Failure; Nonstandard Device; Device Slipped
ON MAY 16TH, 2018, OUR US CLIENT ALERE RANDOMLY SELECTED OUR PRODUCT ONE STEP MULTI-DRUG ORAL FLUID TEST CUBE (LOT NO.W61080201, W61080202, W60680202) FOR INSPECTION. FIFTEEN SALIVA SPONGE COLLECTORS (ACCESSORIES OF THE TEST CUBE) WERE SELECTED AND IT WAS FOUND THAT 5 OF THE 15 FOAM TIPS HAD FALLEN OFF. THIS PRODUCT MEET THE INTERNAL SPECIFICATIONS, IS USED FOR DIAGNOSIS AND THE FAILURE OF THE ACCESSORY MAY LEAD TO A MDR REPORTABLE EVENTS. THE POTENTIAL FAILURE OF THE SPONGE COLLECTOR MAY LEAD TO THE FOLLOWING CONSEQUENCES: (1) AFFECTING THE USE OF THE PRODUCT; (2) CAUSING RISKS OF EATING BECAUSE THE FOAM TIP MAY BE DISLODGED IN THE USER'S MOUTH. WE HAVE CONDUCTED AN INVESTIGATION AND THE CAUSES OF THE FAILURE ARE IDENTIFIED AS FOLLOWS: (1) FOR STRUCTURAL DESIGN: THE OUTER SURFACE OF THE FOAM TIP IS NOT FIXED, AND IT IS ONLY AFFIXED BY HOT-MELT ADHESIVE ON THE END FACE, WHICH MAKES IT EASY TO FALL OFF. (2) FOR PROCESS FLOW: A) ACCORDING TO THE EXISTING PRODUCT TECHNOLOGY, HOT-MELT ADHESIVES MUST BE SPOTTED TO THE PLASTIC PARTS FIRST, AND THEN THE SPONGES WILL BE ASSEMBLED. THE PROCESS CANNOT BE CONTROLLED DUE TO MANUAL OPERATIONS, WHICH MAY CAUSE THE HOTMELT ADHESIVES TO CURE IN AD
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7640818 ↗
Other Test, Methamphetamine, Employment And Insurance Testing, Exempt devices
- T-Cube® TCUBE-7PCPBInstant Technologies, Inc. · Test, Methamphetamine, Employment And Insurance Testing, Exempt1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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