Accu-Chek Fastclix 07531567160Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Fastclix AST Kit USA · Class 2
All models of Accu-Chek Fastclix (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00365702702219), received between Oct 20, 2020 and Oct 20, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Retraction 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
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2020Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10704561 ↗
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
- Accu-Chek Fastclix 05360145001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only7 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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