Urisys 1100 Urine Analyzer 3617556001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00075537253564), received between Oct 28, 2020 and Aug 25, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “No Device Output” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K033548); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429910 ↗
• MalfunctionSep 9, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE NEGATIVE NITRITE, LEUKOCYTE, AND ERYTHROCYTE RESULTS FOR MULTIPLE URINE PATIENT SAMPLES TESTED WITH THE CHEMSTRIP 10 MD URINE TEST STRIPS ON THE URISYS 1100 URINE ANALYZER. ONE EXAMPLE OF DISCREPANT RESULTS FOR A PATIENT WITH SYMPTOMS OF URINARY TRACT INFECTION WAS PROVIDED: THE ANALYZER RESULTS WERE NEGATIVE. THE CUSTOMER'S VISUAL READ OF THE RESULTS WAS POSITIVE (THE CUSTOMER WAS UNABLE TO SPECIFY IF THE RESULTS WERE FOR NITRITES, LEUKOCYTES, OR ERYTHROCYTES.) THE CUSTOMER STATED THAT THE TEST STRIP PADS LOOKED POSITIVE BEFORE THEY WERE PLACED ON THE METER, PROMPTING THE VISUAL READ OF THE TEST STRIP RESULTS. THE RESULTS FROM THE CUSTOMER'S VISUAL READ WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008862 ↗
• MalfunctionMay 14, 2025False Positive Result; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS TESTED WITH THE CHEMISTRIP 10 MD URINE TEST STRIP ON A URISYS 1100 URINE ANALYZER. THE SAMPLES WERE INITIALLY TESTED ON THE METER, AND THE GLUCOSE RESULTS WERE POSITIVE. THE METER RESULTS DID NOT MEET THE PATIENTS' CLINICAL STATUS, AS THE PATIENTS WERE NOT SICK AND WITH NO SYMPTOMS. IN ADDITION, THE RESULTS DID NOT CORRELATE WITH THE VISUAL READING OF THE TEST STRIP. THE PATIENTS WERE TESTED ON AN ACCU-CHEK INFORM METER, AND THE GLUCOSE RESULTS WERE NEGATIVE. NO EXACT RESULTS WERE PROVIDED. THE CUSTOMER WAS NOT SURE WHETHER THE URISYS 1100 RESULT OR THE VISUAL RESULT WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018979 ↗
• MalfunctionMar 7, 2024No Device Output; No Device Output

  THE INITIAL REPORTER COMPLAINED THAT THEY RECEIVED MULTIPLE QUESTIONABLE TEST RESULTS FROM AN UNSPECIFIED NUMBER OF URINE PATIENT SAMPLES TESTED ON THE URISYS 1100 URINE ANALYZER. THE REPORTER STATED THAT THEY WOULD RECEIVE MULTIPLE HIGH RESULTS FOR ALL PARAMETERS FROM THE ANALYZER, AND WHEN COMPARED WITH THE URINE CHEMISTRY TEST STRIP RESULTS, THE RESULTS DID NOT MATCH AND THE ANALYZER RESULTS WERE INCORRECT. THE REPORTER STATED THAT IT WOULD OCCUR RANDOMLY AND MIGHT BE "TWO IN A ROW" AND THEN THE RESULTS WOULD BE "OKAY" FOR A FEW TESTS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AS THEY WOULD QUESTION THE RESULTS WHEN MULTIPLE POSITIVES OCCURRED AND THEY WOULD RUN THE PATIENT SAMPLE UNTIL THEY GOT A RESULT THAT MATCHED THE VISUAL READING; THEY WOULD ALSO RECEIVE AN ERROR "E2 WRONG STRIP". THE REPORTER WAS NOT ABLE TO PROVIDE SPECIFIC EXAMPLES OF PARAMETERS WITH QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854832 ↗
• MalfunctionAug 26, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED DISCREPANT RESULTS FOR 1 PATIENT WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1100 ANALYZER. A VISUAL READING OF THE CHEMSTRIP INDICATED THE LEUKOCYTE, GLUCOSE, BLOOD, AND PROTEIN RESULTS WERE NEGATIVE/NORMAL. THE URISYS 1100 ANALYZER RESULTS INDICATED THE RESULTS WERE POSITIVE. THE LEUKOCYTE RESULT WAS 500. THE GLUCOSE RESULT WAS 250. THE BLOOD RESULT WAS 50. THE PROTEIN RESULT WAS POSITIVE, BUT AN EXACT RESULT WAS NOT PROVIDED. THE UNITS OF MEASURE WERE NOT PROVIDED. THE PATIENT WAS NOT TREATED BASED ON THE RESULTS. THE NEGATIVE RESULTS WERE BELIEVED TO BE CORRECT. THE CHEMSTRIP LOT NUMBER IS 58170605 WITH AN EXPIRATION DATE OF 30-APR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302885 ↗
• MalfunctionAug 17, 2021No Device Output; Communication or Transmission Problem; No Device Output; Communication or Transmission Problem

  THE INITIAL REPORTER COMPLAINED OF A SOFTWARE ISSUE WITH A URISYS 1100 URINE ANALYZER, SOFTWARE VERSION 6.6. THE CUSTOMER STATED THE ANALYZER DID NOT TRANSMIT A PATIENT RESULT FROM (B)(6) 2021. ON (B)(6) 2021 POSITIVE QC WAS RUN AND THE QC RESULTS WERE TRANSMITTED WITH PATIENT ID (B)(6)FROM (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332042 ↗
• MalfunctionOct 28, 2020False Negative Result; False Positive Result; High Readings; Low Readings; False Negative Result; False Positive Result; High Readings; Low Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE FALSE NEGATIVE AND FALSE POSITIVE LEUKOCYTE RESULTS FOR "8 OR 9 PATIENTS" WITH CHEMSTRIP 10 MD TEST STRIPS ON A URISYS 1100 ANALYZER. THE PATIENTS' AGES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' GENDERS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 10749742 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033548. One submission often covers many models, so check the product and lot details in each record.

• Z-0301-2019 · Sep 24, 2018 · Terminated
  Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and