MICROLET® 6586 / 6586WRecalls & reported problems
Ascensia Diabetes Care US Inc. · Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00301936586218), received between Apr 12, 2023 and Aug 15, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Component Missing3
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2023Component Missing; Component Missing
A CUSTOMER CALLED TO REPORT THAT TWO OF THE LANCETS FROM THE BOX OF THE MICROLET LANCETS RECEIVED BY THE CUSTOMER DID NOT HAVE A PROTECTIVE COVER ON IT. THE CUSTOMER ACCIDENTALLY PRICKED HIS FINGER WITH THE UNCOVERED LANCET. HOWEVER, NO MEDICAL ATTENTION WAS REQUIRED. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: Needle Stick/Puncture
MAUDE report 17548370 ↗InjuryApr 18, 2023Component Missing; Component Missing
A CUSTOMER CALLED TO REPORT THAT SHE PURCHASED A BOX OF MICROLET LANCETS. WHEN THE CUSTOMER OPENED THE BOX, SHE FOUND THAT 15 OF 100 LANCETS IN THE BOX DID NOT HAVE PROTECTIVE COVERS ON THEM. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION, AS THE CUSTOMER DISCARDED THE LANCETS. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16761435 ↗InjuryApr 12, 2023Component Missing; Component Missing
A CUSTOMER CALLED TO REPORT THAT ONE OF THE LANCETS FROM THE BOX OF MICROLET LANCETS RECEIVED BY THE CUSTOMER DID NOT HAVE A PROTECTIVE COVER ON IT. THE CUSTOMER ACCIDENTALLY PRICKED HER FINGER WITH THE UNCOVERED LANCET. HOWEVER, NO MEDICAL ATTENTION WAS REQUIRED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT LANCETS WERE SENT TO THE CUSTOMER.
Patient problems: Needle Stick/Puncture
MAUDE report 16723890 ↗
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-30-IIShandong 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
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.