Accu-Chek FastclixRecalls & reported problems across all models
Roche Diabetes Care GmbH · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 122
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of Accu-Chek Fastclix by Roche Diabetes Care GmbH in the FDA's device registry (GUDID). Together they are named in 122 adverse event reports in the FDA's MAUDE database, received between Sep 9, 2019 and Mar 20, 2026 — classified as 122 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (118 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. 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
Reports received per month, all models
Most reported Accu-Chek Fastclix problems
Device problems
- Retraction Problem118
- Delivered as Unsterile Product2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions87
- No Consequences Or Impact To Patient30
- No Known Impact Or Consequence To Patient3
- Device Embedded In Tissue or Plaque1
- Needle Stick/Puncture1
Accu-Chek Fastclix models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Accu-Chek Fastclix 05864666160Multiple Use Blood Lancet For Single Patient Use Only70 reports
- Accu-Chek Fastclix 07523211001Multiple Use Blood Lancet For Single Patient Use Only44 reports
- Accu-Chek Fastclix 05360145001Multiple Use Blood Lancet For Single Patient Use Only7 reports
- Accu-Chek Fastclix 07531567160Multiple Use Blood Lancet For Single Patient Use Only1 report
Recent Accu-Chek Fastclix adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647574 ↗MalfunctionFeb 16, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345297 ↗MalfunctionFeb 10, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304469 ↗MalfunctionNov 11, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522717 ↗MalfunctionOct 23, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE NEEDLES ARE EXPOSED/VISIBLE. THE LANCETS WERE EXPOSED FROM THE DRUM OUT OF THE BOX AS THE NEEDLES WERE VISIBLE. THE SEAL OF THE BOX WAS BROKEN AS WELL. THE CUSTOMER SAID THAT THE DEFECT WAS APPARENT WHEN HE RECEIVED THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366748 ↗MalfunctionOct 20, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23343166 ↗MalfunctionOct 17, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322866 ↗MalfunctionOct 17, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320754 ↗MalfunctionOct 16, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23309442 ↗MalfunctionJul 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563722 ↗MalfunctionJul 8, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437701 ↗MalfunctionJul 7, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE. THE ISSUE OCCURRED AGAIN WITH A NEW LANCET DRUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414148 ↗MalfunctionMay 30, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE. THE PATIENT REPORTED THAT SHE PRICKED HER FINGER DUE TO THE PROTRUDING LANCET BUT DID NOT REQUIRE MEDICAL TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115243 ↗MalfunctionApr 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880748 ↗MalfunctionMar 18, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21628712 ↗
Other Roche Diabetes Care GmbH products
All Roche Diabetes Care GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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