Accu-Chek Softclix 03144844001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Softclix Lancets 10/pk · Class 2
All models of Accu-Chek Softclix (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630084937), received between Nov 7, 2025 and Mar 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Material Separation
IT WAS REPORTED THAT THE STERILITY CAP WAS MISSING FROM ONE LANCET IN THE BOX RESULTING IN AN ACCIDENTAL FINGER STICK. NO MEDICAL ATTENTION WAS REQUIRED FOR THE FINGER STICK.
Patient problems: Needle Stick/Puncture
MAUDE report 24727411 ↗MalfunctionNov 7, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE LANCET WAS ALREADY ON THE LANCING DEVICE WITHOUT THE CAP. PACKAGE WAS OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23494347 ↗
Other Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature devices
- Accu-Chek Softclix 05181186001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature133 reports
- OneTouch Delica Plus Lancet 02400801Asahi Polyslider Company,Limited · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1 recall0 reports
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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
- TRUEplus Good Neighbor Pharmacy TRUEplus Sterile LancetsTrividia Health, Inc. · 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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