T-Cube® Tcube-9BUPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858945006881), received between Jun 27, 2018 and Jun 27, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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: 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 ↗