CHEMSTRIP 10 UA TEST STRIPS 11895354160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00075537180037), received between Nov 30, 2021 and Dec 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2023False Negative Result; Device Difficult to Setup or Prepare; False Negative Result; Device Difficult to Setup or Prepare

  THE INITIAL REPORTER RECEIVED QUESTIONABLE LEUKOCYTE RESULTS FOR FOUR URINE PATIENT SAMPLES TESTED ON THE URISYS 1100 URINE ANALYZER US WITH SERIAL NUMBER (B)(6). THE REPORTER STATED THAT THE METER RESULTS WERE NOT ALIGNED WITH THE PATIENTS' SYMPTOMS PROMPTING THEM TO SEND THE URINE SAMPLES TO THE LABORATORY. RESULTS FOR THE FOUR URINE PATIENT SAMPLES: THE METER RESULTS WERE NEGATIVE FOR LEUCOCYTES. THE LABORATORY RESULTS WERE POSITIVE. THE ACTUAL LABORATORY RESULTS WERE REQUESTED BUT NOT PROVIDED. THE PATIENTS WERE TREATED BASED ON THE LABORATORY RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246712 ↗
• MalfunctionNov 30, 2021False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE LEUKOCYTES RESULT FOR ONE PATIENT URINE SAMPLE WITH A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE LEUKOCYTE RESULT FROM THE METER WAS NEGATIVE. THE PATIENT SAMPLE WAS SENT FOR A LABORATORY CULTURE THAT REPORTED >100,000 E. COLI. NO URINALYSIS DIPSTICK TEST WAS PERFORMED AT THE LABORATORY. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897543 ↗