CLINITEK Novus Automated Urine Chemistry AnalyzerRecalls & reported problems across all models
Siemens Healthcare Diagnostics Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of CLINITEK Novus Automated Urine Chemistry Analyzer by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2018 and Nov 20, 2024 — classified as 23 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CLINITEK Novus Automated Urine Chemistry Analyzer problems
Device problems
- False Negative Result18
- Accessory Incompatible1
- Low Test Results1
- Non Reproducible Results1
- Smoking1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient2
CLINITEK Novus Automated Urine Chemistry Analyzer models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CLINITEK Novus® Automated Urine Chemistry Analyzer 10697937INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)20 reports
- CLINITEK Novus® Automated Urine Chemistry Analyzer 10494134NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)3 reports
Recent CLINITEK Novus Automated Urine Chemistry Analyzer adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT TWO PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738173 ↗MalfunctionNov 20, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT TWO PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738017 ↗MalfunctionNov 20, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT ONE PATIENT PRODUCED A FALSE NEGATIVE RED BLOOD CELL (RBC) RESULT ON THE NOVUS. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737692 ↗MalfunctionNov 15, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20698427 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT TWO PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584871 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584867 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584850 ↗MalfunctionOct 31, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT ONE PATIENT PRODUCED A FALSE NEGATIVE RED BLOOD CELL (RBC) RESULT ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON THE UAS800 (SEDIMENT TEST) WHICH YIELDED A POSITIVE RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584834 ↗MalfunctionOct 23, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT FOUR PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20519064 ↗MalfunctionOct 23, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT ONE PATIENT PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518918 ↗MalfunctionOct 23, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED THAT THREE PATIENTS PRODUCED FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING THE NOVUS CASSETTES 450 LOT. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514435 ↗MalfunctionOct 10, 2024False Negative Result; False Negative Result
THE CUSTOMER ALLEGED TWO FALSE NEGATIVE RED BLOOD CELL (RBC) RESULTS ON THE NOVUS WHILE USING TWO DIFFERENT LOTS OF THE NOVUS CASSETTES. COMPARISON TESTING WAS PERFORMED ON BOTH THEIR LABORATORY ANALYZER AND UAS800 (SEDIMENT TEST) WHICH YIELDED POSITIVE RESULTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416155 ↗MalfunctionJul 23, 2024Low Test Results; Low Test Results
THE CUSTOMER ALLEGED AN ISSUE WITH THE CLINITEK NOVUS VERSES THE ATELLICA UAS 800 AFTER INSTALLATION WHERE THE NOVUS WAS GIVING LESS LEUKOCYTES (LEU) THAN WHITE BLOOD CELLS (WBC). THE CASSETTE WAS CALIBRATED AGAIN BUT KEEPS GIVING LESS LEU THAN IT SHOULD. THE MICROSCOPIC PICTURES SHOW THAT THE ATELLICA UAS 800 IS MEASURING THE PARTICLE WELL, BUT IT DOES NOT IN ANY WAY MEET THE MEASUREMENTS IN THE NOVUS. THE ESCALATION WAS OPENED AGAINST THE CLINITEK NOVUS, BUT THE CUSTOMER DOES NOT KNOW WHICH ANALYZER'S RESULTS ARE EXPECTED TO BE TRUE. THERE WAS NO REPORT OF HARM DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19809967 ↗MalfunctionDec 2, 2022False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEIR CLINITEK NOVUS INSTRUMENT GAVE A FALSE NEGATIVE LEUKOCYTE RESULT COMPARED TO RETESTING THE SAME PAITENT SAMPLE USING A VISUAL READ MULTISTIX 10SG URINE STRIP . THE CUSTOMER ALSO REPORTED THE APPERANCE OF THIS PAITENT SAMPLE WAS NOTABLY CLOUDY. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15901292 ↗MalfunctionDec 1, 2022False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEIR CLINITEK NOVUS INSTRUMENT GAVE A FALSE NEGATIVE LEUKOCYTE RESULT COMPARED TO RETESTING THE SAME PATIENT SAMPLE USING A VISUAL READ MULTISTIX 10SG URINE STRIP. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15899522 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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