Accu-Chek Safe-T-Pro 03450074001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00365702702196), received between Jul 20, 2021 and Feb 2, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ORDER OF ACCU-CHEK SAFE-T-PRO LANCETS AND THEY WERE CONTAMINATED WITH MOLD. THERE WAS GREEN AND BROWN MOLD ON THE INSIDE OF THE PACKAGING AND ON THE PACKAGE INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424495 ↗
• MalfunctionOct 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH A BOX OF ACCU-CHEK SAFE-T-PRO PLUS LANCETS. THE DATE OF EVENT IS AN APPROXIMATION. THE REPORTER STATED THIS OCCURRED "SEVERAL WEEKS AGO." THE CUSTOMER STATED THE STERILITY CAP OF THE LANCETS WAS VERY DIFFICULT TO REMOVE. WHEN THE CUSTOMER FINALLY GOT THE STERILITY CAP OFF, THE NEEDLE CAME OUT WITH THE CAP. THE CUSTOMER STATED THE NEEDLE REMAINED IN THE STERILITY CAP BUT COULD NOT REMEMBER IF THE NEEDLE WAS COMPLETELY COVERED/ENCLOSED BY THE CAP OR IF IT STUCK OUT. THE CUSTOMER WAS NOT INJURED BY THE NEEDLE THAT CAME OUT ALONG WITH THE CAP. THE CUSTOMER WAS NOT SURE IF SHE WAS TWISTING THE STERILITY CAP OR PULLING THE STERILITY CAP WHEN ATTEMPTING TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627922 ↗
• MalfunctionJul 20, 2021Ejection Problem; Ejection Problem

  THERE WAS A COMPLAINT OF HAVING TROUBLE GETTING ENOUGH BLOOD WITH THE ACCU-CHEK SAFE-T-PRO PLUS LANCET. THE CUSTOMER STATED IT DOES NOT FEEL LIKE THE LANCET IS GOING INTO HIS FINGER STRAIGHT ON BUT AT AN ANGLE AND THEREFORE IS NOT ABLE TO GET ENOUGH BLOOD. THERE WAS NO ALLEGATION OF ANY INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196606 ↗