T-CubeRecalls & reported problems across all models

We found 6 models of T-Cube by Instant Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and Jun 27, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (7 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

T-Cube recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 ↗

Most reported T-Cube problems

T-Cube models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• T-Cube® TCUBE-7PCPB

  Test, Methamphetamine, Employment And Insurance Testing, Exempt
  1 recall0 reports
• T-Cube® Tcube-9BUP

  Test, Methadone, Employment And Insurance Testing, Exempt
  2 reports
• T-Cube® Tcube-6O

  Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
  2 reports
• T-Cube® Tcube-10BUP

  Test, Barbiturate, Employment And Insurance Testing, Exempt
  1 report
• T-Cube® Tcube-8BUP

  Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
  1 report
• T-Cube® Tcube-6MB

  Test, Methamphetamine, Employment And Insurance Testing, Exempt
  1 report

Recent T-Cube adverse event reports

The 7 most recent reports across all models, 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 (B)(6) 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 ADVANC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640821 ↗
• MalfunctionJun 27, 2018Fail-Safe Design Failure; Nonstandard Device; Device Slipped; Fail-Safe Design Failure; Nonstandard Device; Device Slipped

  ON (B)(6) 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 ADVANCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640819 ↗
• 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 ↗
• MalfunctionJun 27, 2018Fail-Safe Design Failure; Nonstandard Device; Device Slipped; Detachment of Device or Device Component; Fail-Safe Design Failure; Nonstandard Device; Device Slipped

  ON (B)(6) 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 ADVANC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640788 ↗
• MalfunctionJun 27, 2018Fail-Safe Design Failure; Nonstandard Device; Device Slipped; Fail-Safe Design Failure; Nonstandard Device; Device Slipped

  ON (B)(6) 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 ADVANC

  Patient problems: No Code Available

  MAUDE report 7640787 ↗
• MalfunctionJun 27, 2018Fail-Safe Design Failure; Nonstandard Device; Device Slipped; Fail-Safe Design Failure; Nonstandard Device; Device Slipped

  ON (B)(6) 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: AFFECTING THE USE OF THE PRODUCT; 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: 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. FOR PROCESS FLOW: 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 ADVANCE AND THE ADHESION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640778 ↗
• MalfunctionJun 27, 2018Fail-Safe Design Failure; Nonstandard Device; Device Slipped; Fail-Safe Design Failure; Nonstandard Device; Device Slipped

  ON (B)(6) 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: AFFECTING THE USE OF THE PRODUCT; 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: 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. FOR PROCESS FLOW: 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 ADVANCE AND THE ADHESION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640776 ↗

Other Instant Technologies, Inc. products

• iCup5 models · 3 reports · 1 recall
• AlereTM iScreen2 models · 1 reports · 1 recall
• Alere iCup Dx Pro 22 models · 0 reports · 1 recall