CLINITEK Status+ AnalyzerRecalls & reported problems across all models
Siemens Healthcare Diagnostics Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 90
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of CLINITEK Status+ Analyzer by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 90 adverse event reports in the FDA's MAUDE database, received between Sep 7, 2017 and Mar 19, 2026 — classified as 90 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (42 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 Status+ Analyzer problems
Device problems
- False Negative Result42
- Smoking21
- Electrical /Electronic Property Problem17
- Non Reproducible Results4
- Low Test Results2
- Use of Device Problem2
- Insufficient Device Problem Information1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient18
- No Patient Involvement13
- No Known Impact Or Consequence To Patient5
- Pregnancy3
- Insufficient Information2
- Nausea1
CLINITEK Status+ Analyzer models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CLINITEK Status®+ Analyzer 10379675ENZYMATIC METHOD, CREATININE89 reports
- CLINITEK Status®+ Analyzer 10379677DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)1 report
Recent CLINITEK Status+ Analyzer adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026False Negative Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULT COMPARED TO RETESTING ON A LABORATORY INSTRUMENT USING SERUM HCG METHOD. THE PATIENT'S PREGNANCY WAS CONFIRMED RETEST BY SERUM HCG. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24636501 ↗MalfunctionMar 18, 2026Smoking
CUSTOMER REPORTED THAT THE STATUS+ DEVICE PRODUCED A SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625221 ↗MalfunctionDec 1, 2025Smoking; Smoking
THE CUSTOMER REPORTED THEIR CLINITEK STATUS+ DEVICE WAS SMOKING. THE DEVICE LOST CONNECTIVITY TO THE NETWORK AND STARTED SMOKING. THERE WAS NO VISIBLE FIRE. THE CUSTOMER REMOVED THE BATTERIES AND DISCONNECTED THE DEVICE FROM THE BASE. THE CUSTOMER TRIED POWERING ON THE DEVICE, BUT IT WAS UNSUCCESSFUL. THERE IS NO REPORT OF HARM DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682365 ↗MalfunctionSep 3, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULT ON THEIR CLINITEK STATUS+ INSTRUMENT COMPARED TO SERUM TESTING. THE PATIENT'S PREGNANCY WAS CONFIRMED FROM THE REPEAT TESTING. THERE IS NO REPORTED INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949412 ↗MalfunctionSep 2, 2025Smoking; Smoking
CUSTOMER REPORTED THAT THE STATUS+ DEVICE PRODUCED A SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931576 ↗MalfunctionAug 18, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT LOW BLOOD RESULT ON THEIR CLINITEK STATUS+ INSTRUMENT COMPARED TO LAB TESTING. THE PATIENT'S BLOOD RESULT WAS CONFIRMED FROM THE REPEAT TESTING. THERE IS NO REPORTED INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22825041 ↗MalfunctionAug 12, 2025Smoking; Smoking
CUSTOMER REPORTED THAT THE STATUS+ DEVICE PRODUCED A SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22780715 ↗MalfunctionJun 27, 2025Smoking; Smoking
CUSTOMER REPORTED THAT THE STATUS+ DEVICE PRODUCED A SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22343301 ↗MalfunctionJun 18, 2025Smoking; Smoking
CUSTOMER REPORTED THAT THE STATUS+ DEVICE PRODUCED SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282949 ↗MalfunctionMar 26, 2025Smoking; Smoking
CUSTOMER REPORTED THAT THE STATUS+ DEVICE PRODUCED A SMOKING SMELL. VISIBLE SMOKE WAS OBSERVED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21695155 ↗MalfunctionJan 28, 2025Smoking; Smoking
CUSTOMER REPORTS THAT THEIR CLINITEK STATUS+ WAS VERY HOT, SMOKING, HISSING, AND THE THERMAL PAPER IS BLACK. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252412 ↗MalfunctionJan 16, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULT ON THEIR CLINITEK STATUS+ INSTRUMENT COMPARED TO SERUM TESTING. THE PATIENT'S PREGNANCY WAS CONFIRMED FROM REPEAT TESTING. THERE IS NO REPORTED INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167581 ↗MalfunctionSep 11, 2024False Negative Result; False Negative Result
THE CUSTOMER OBTAINED FALSE NEGATIVE LEUKOCYTE RESULTS ON ONE PATIENT COMPARED TO RETESTING ON THEIR LABORATORY INSTRUMENT. REPEAT TESTING WAS PERFORMED FROM THE SAME SAMPLE. TIME BETWEEN TESTS WAS NOT PROVIDED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20194626 ↗MalfunctionMay 24, 2024False Negative Result; False Negative Result
THE CUSTOMER OBTAINED FALSE NEGATIVE LEUKOCYTE RESULTS ON TWO PATIENTS COMPARED TO RETESTING ON THEIR LABORATORY INSTRUMENT. REPEAT TESTING WAS PERFORMED FROM THE SAME SAMPLE. TIME BETWEEN TESTS WAS NOT PROVIDED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397283 ↗MalfunctionApr 25, 2024Smoking; Smoking
THE CUSTOMER STATED THAT THERE WAS VISIBLE SMOKE COMING FROM THEIR CLINITEK STATUS+. NO FLAMES WERE SEEN. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19180547 ↗
Other Siemens Healthcare Diagnostics Inc. products
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- ADVIA Centaur CA 19-92 models · 124 reports · 2 recalls
- Atellica IM eE23 models · 65 reports · 3 recalls
- RAPIDPoint 500 Measurement Cartridge4 models · 3 reports · 4 recalls
- ADVIA Centaur eE23 models · 22 reports · 3 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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