CLINITEK Advantus® Analyzer 10636672Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Siemens Healthcare Diagnostics Reagent Strips for Urinalysis, such as Multistix® 10 SG and Multistix PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine ratio, Specific Gravity, and Urobilinogen. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414593562), received between Mar 6, 2018 and Oct 14, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 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 16, 2026.
Most reported problems
Device problems
- False Negative Result3
- Non Reproducible Results2
- Smoking1
Patient problems
- No Consequences Or Impact To Patient3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2021Smoking; Smoking
THE CUSTOMER REPORTED THAT THEIR CLINITEK ADVANTUS SN (B)(4) HAD URINE SPILLED ACCIDENTLY INSIDE THE ANALYZER AND THE INSTRUMENT STARTED SMOKING NEAR THE PRINTER. THE OPERATOR IMMEDIATELY UNPLUGGED THE UNIT. THE CUSTOMER HAS CONFIRMED THAT THERE ARE NO INJURIES OR DAMAGES TO ANY PROPERTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12636583 ↗MalfunctionApr 16, 2021Non Reproducible Results; Non Reproducible Results
THE CUSTOMER REPORTED A FALSE NEGATIVE LEUKOCYTE ON ONE PATIENT'S URINE SAMPLE ON THE CLINITEK ADVANTUS WHEN COMPARED TO THE VISUAL READ OF THE MULTISTIX 10 SG AND THE MICROSCOPIC EXAM OF THE URINE SEDIMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11679089 ↗MalfunctionOct 21, 2019Non Reproducible Results; Non Reproducible Results
THE CUSTOMER REPORTED DISCREPANT LEUKOCYTE RESULTS ON THE CLINITEK ADVANTUS WHEN COMPARED TO THE MICROSCOPIC EXAMINATION OF THE URINE SEDIMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9215846 ↗MalfunctionSep 5, 2018False Negative Result; False Negative Result
THE CUSTOMER REPORTED A FALSE NEGATIVE LEUKOCYTE RESULT ON THE CLINITEK ADVANTUS USING MULTISTIX 10 SG WHEN COMPARED TO A NON-SIEMENS REFERENCE LAB AND THE MICROSCOPIC EXAMINATION OF THE SEDIMENT. THERE WAS NO REPORT OF INJURY DO TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7848425 ↗MalfunctionJul 30, 2018False Negative Result; False Negative Result
THE CUSTOMER REPORTED (B)(6) LEUKOCYTES IN URINE ON TWO PATIENTS TESTED ON THE CLINITEK ADVANTUS WHEN COMPARED TO THE MICROSCOPIC READING OF THE SEDIMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7731692 ↗MalfunctionMar 6, 2018False Negative Result; False Negative Result
THE CUSTOMER REPORTED FALSE NEGATIVE LEUKOCYTES ON THE CLINITEK ADVANTUS USING MULTISTIX 10 SG WHEN COMPARED TO 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 7317210 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page