Accu-Chek Fastclix 05360145001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Fastclix 102 Lancets Rtl 12/cs · Class 2
All models of Accu-Chek Fastclix (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00365702288102), received between Mar 5, 2020 and Feb 16, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (3 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
- Retraction Problem3
- Delivered as Unsterile Product2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Needle Stick/Puncture1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionFeb 7, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE LANCET WAS EXPOSED, OUTSIDE OF THE LANCET DRUM, OUT OF BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16310237 ↗MalfunctionMar 29, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A FRAGMENT OF THE LANCET BROKE OFF IN THE CUSTOMER'S FINGER. THE CUSTOMER REPORTED THAT THIS HAPPENED AROUND 3:00PM ON (B)(6) 2021, AND THE FOLLOWING DAY HE NOTICED A BUMP AND SWELLING OF THE FINGER. THE CUSTOMER WAS ABLE TO SELF-TREAT AND REMOVED THE LANCET FRAGMENT FROM HIS FINGER. NO MEDICAL TREATMENT WAS REQUIRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11585459 ↗MalfunctionDec 2, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
THE CALLER REPORTED THAT HE OPENED A NEW BOX OF ACCU-CHEK FASTCLIX LANCET DRUMS; UPON REMOVING THE LANCETS FROM THE BOX, ONE OF THE LANCET DRUMS BROKE INTO PIECES AND THE LANCET CAME OUT. THE CUSTOMER RECEIVED AN ACCIDENTAL LANCET STICK ON THE PALM OF THE HAND. NO MEDICAL TREATMENT WAS REQUIRED.
Patient problems: Needle Stick/Puncture
MAUDE report 10931379 ↗MalfunctionMar 23, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE LANCET BROKE OFF IN THE PATIENT'S FINGER. THE PATIENT WAS ABLE TO REMOVE THE LANCET FRAGMENT BY HIMSELF AND DID NOT REQUIRE TREATMENT BY A MEDICAL PROFESSIONAL. HE RECEIVED AN X-RAY WHICH SHOWED PIECES OF THE LANCET REMAINED IN HIS FINGER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9864944 ↗MalfunctionMar 5, 2020Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCETS WERE UNCAPPED OUT OF BOX.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9792215 ↗
Other Multiple Use Blood Lancet For Single Patient Use Only devices
- Accu-Chek Fastclix 05864666160Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only70 reports
- One +Step LF-TL-28-IShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- One +Step LF-TL-23-IShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- One +Step LF-TL-30-IIShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- Accu-Chek Coaguchek Softclix 07313462001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only46 reports
- Accu-Chek Fastclix 07523211001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only44 reports
- Accu-Chek Coaguchek Softclix 08120242001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only11 reports
- MICROLET® 6586 / 6586WAscensia Diabetes Care US Inc. · Multiple Use Blood Lancet For Single Patient Use Only3 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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