CHEMSTRIP 2 GP URINE TEST STRIPS 11895362160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00075537171455), received between Aug 27, 2018 and Aug 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023False Negative Result; Device Difficult to Setup or Prepare; False Negative Result; Device Difficult to Setup or Prepare

  THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE NEGATIVE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS TESTED FOR LEUCOCYTES, BLOOD AND PROTEIN WITH CHEMSTRIP 10 WITH SG URINE TEST STRIPS. THE RESULTS ARE BEING QUESTIONED AS THE PATIENTS WERE PRESENTING WITH URINARY TRACT INFECTION (UTI) SYMPTOMS, HOWEVER, THE TEST STRIP PARAMETERS WERE NEGATIVE. THE CULTURE FROM THE LABORATORY WAS RETURNED AS POSITIVE FOR THESE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552034 ↗
• MalfunctionAug 27, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF FALSE POSITIVE NITRITE RESULTS FOR SOME PATIENT URINE SAMPLES FROM CHEMSTRIP 10 SG TEST STRIPS. THE ISSUE DID NOT OCCUR WITH ALL PATIENT URINE SAMPLES. THE CUSTOMER DID VISUAL TESTS AND NOTICED SHE WAS GETTING POSITIVE NITRITE RESULTS. SHE EXPECTED THE RESULTS TO BE NEGATIVE AS SHE DID NOT SEE BACTERIA IN THE SEDIMENT OF THE URINE SAMPLES WITH A MICROSCOPE. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STORED THE TEST STRIPS CORRECTLY AND THE STRIP PAD WAS WHITE BEFORE USE. THE CUSTOMER DID NOT USE URINE SAMPLES THAT WERE RED OR PINK. THE QC WAS ACCEPTABLE. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THIS MEDWATCH WILL COVER TEST STRIP LOT 22262702. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON TEST STRIP LOT 21650803.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818033 ↗
• MalfunctionAug 27, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF FALSE POSITIVE NITRITE RESULTS FOR SOME PATIENT URINE SAMPLES FROM CHEMSTRIP 10 SG TEST STRIPS. THE ISSUE DID NOT OCCUR WITH ALL PATIENT URINE SAMPLES. THE CUSTOMER DID VISUAL TESTS AND NOTICED SHE WAS GETTING POSITIVE NITRITE RESULTS. SHE EXPECTED THE RESULTS TO BE NEGATIVE AS SHE DID NOT SEE BACTERIA IN THE SEDIMENT OF THE URINE SAMPLES WITH A MICROSCOPE. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STORED THE TEST STRIPS CORRECTLY AND THE STRIP PAD WAS WHITE BEFORE USE. THE CUSTOMER DID NOT USE URINE SAMPLES THAT WERE RED OR PINK. THE QC WAS ACCEPTABLE. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THIS MEDWATCH WILL COVER TEST STRIP LOT 21650803. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON TEST STRIP LOT 22262702.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818019 ↗