TRUEplus TRUEplus Sterile Lancets (REF 743500)Recalls & reported problems
Trividia Health, Inc. · TRUEplus Sterile Lancets · Class 2
All models of TRUEplus (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00021292000226), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 18, 2026.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Material Twisted/Bent1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2021Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent
CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS 28G LANCETS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT HE EXPERIENCED PAIN AFTER USING THE LANCET, AND WHEN HE LOOKED IN THE LANCET, IT HAD TWO NEEDLES (DOUBLE NEEDLE). CUSTOMER STATED THAT ONE OF THE NEEDLES WAS BENT. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.
Patient problems: Pain
MAUDE report 11740826 ↗
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- FreeStyle 70469Abbott Diabetes Care Inc · Single use only blood lancet without an integral sharps injury prevention feature1 recall0 reports
- Accu-Chek Softclix 11893238160Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature8 reports
- Accu-Chek Softclix 05509661001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature5 reports
- TRUEplus TRUEplus Sterile LancetsTrividia Health, Inc. · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature4 reports
- Accu-Chek Softclix 03144844001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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