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CLINITEK Novus® Automated Urine Chemistry Analyzer 10494134Recalls & reported problems

Siemens Healthcare Diagnostics Inc. · The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu · Class 1

All models of CLINITEK Novus Automated Urine Chemistry Analyzer (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414981130), received between Sep 20, 2018 and Nov 14, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (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

Device problems

  • Accessory Incompatible1
  • False Negative Result1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient3

Recent adverse event reports

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

  • MalfunctionNov 14, 2019False Negative Result; False Negative Result

    THE CUSTOMER REPORTED FALSE NEGATIVE URINE LEUKOCYTE RESULTS ON FOUR PATIENTS ON THE CLINITEK NOVUS WHEN COMPARED TO THE MICROSCOPIC EXAMINATION OF THE URINE SEDIMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9322730 ↗
  • MalfunctionFeb 15, 2019Use of Device Problem; Use of Device Problem

    THE CUSTOMER REPORTED FALSE NEGATIVE LEUKOCYTES ON THE CLINITEK NOVUS (S/N (B)(4)) WHEN COMPARED TO THE SAME CLINITEK NOVUS AFTER BEING RECALIBRATED, ANOTHER CLINITEK NOVUS (S/N UNKNOWN) AND THE MICROSCOPIC EXAMINATION OF THE SEDIMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8343552 ↗
  • MalfunctionSep 20, 2018Accessory Incompatible; Accessory Incompatible

    THE CUSTOMER REPORTED THAT IN THE BOX OF THE REAGENT CARDS (PRO12) USED ON THE NOVUS, SOME WERE ASSEMBLED IN THE OPPOSITE DIRECTION SO THAT THE TEST PADS WERE READ BY THE DEVICE IN THE INCORRECT ORDER. THE CUSTOMER STATED THAT THEY RECEIVED INCORRECT PROTEIN RESULTS THAT WERE REPORTED TO THE PHYSICIAN. THE LAB TECHNICIAN RE-RAN THE SAMPLES AND GOT CORRECT RESULTS AND A CORRECTED REPORT WAS ISSUED. SIEMENS REQUESTED THE RESULTS BUT THEY HAVE NOT BEEN PROVIDED. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7895822 ↗

Other NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) devices

All NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) devices →

Sources and updates

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