CLINITEK Status®+ Analyzer 10379675Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Siemens CLINITEK Status+ urine analyzer appears in 91 adverse event reports, with no deaths and no injuries. Many reports describe false negative test results, including pregnancy tests that read negative when a repeat test was positive, and units giving off smoke or a smell. Some reports describe electrical faults. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00630414574639), received between Sep 7, 2017 and Mar 19, 2026 — classified as 89 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (41 reports).
4 other recalls cover devices cleared under the same FDA submission (K091216); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result41
- 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 Patient4
- Pregnancy3
- Insufficient Information2
- Nausea1
Recent adverse event reports
The 25 most recent of 89 reports, 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 ↗MalfunctionMar 28, 2024Smoking; Smoking
THE CUSTOMER REPORTED THAT SMOKE WAS SEEN COMING FROM THEIR CLINITEK STATUS+ INSTRUMENT. THE CUSTOMER WAS UNABLE TO DETERMINE THE EXACT SOURCE OF THE SMOKE. THE CUSTOMER STATED THAT THEY USE THE ORIGINAL POWER SUPPLY. NO BATTERIES, SURGE PROTECTOR OR CONNECT BASE WAS IN USE AT THE TIME OF THE EVENT AND NO SPILLS ON THE INSTRUMENT OCCURRED. THE CUSTOMER HAS POWERED OFF AND UNPLUGGED THE INSTRUMENT. THERE IS NO REPORT OF INJURY OR DAMAGE TO PROPERTY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995043 ↗MalfunctionJan 30, 2024False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULTS COMPARED TO RETESTING ON THE SAME INSTRUMENT, A LABORATORY INSTRUMENT AND SERUM TESTING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18608351 ↗MalfunctionJan 22, 2024Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THEIR STATUS+ INSTRUMENT PRODUCED VISIBLE SMOKE AND A BURNT SMELL. THE CUSTOMER STATED THAT THEY WERE USING BOTH BATTERIES AND A POWER CORD AT THE TIME OF THE EVENT. THE CUSTOMER WAS ADVISED TO IMMEDIATELY UNPLUG THE UNIT AND REMOVE IT FROM SERVICE. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552287 ↗MalfunctionJan 8, 2024Smoking; Smoking
THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ INSTRUMENT PRODUCED SMOKE AND A BURNT SMELL. THEY STATED THAT THERE WERE NO SPARKS OR VISIBLE FLAMES. THE INSTRUMENT WAS IMMEDIATELY UNPLUGGED AND REMOVED FROM SERVICE. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18463354 ↗MalfunctionOct 3, 2023False Negative Result; False Negative Result
THE CUSTOMER STATED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULT ON ONE PATIENT FROM THEIR STATUS+ ANALYZER COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. THE CUSTOMER STATED THE POSITIVE RESULT WAS CONFIRMED BY A SCAN. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862139 ↗MalfunctionSep 12, 2023False Negative Result; False Negative Result
THE CUSTOMER STATED THAT THEY RECEIVED A FALSE NEGATIVE LEUKOCYTE RESULT COMPARED TO RETESTING OF A DIFFERENT SAMPLE ON A VISUALLY READ STRIP AND TESTING ON A LABORATORY INSTRUMENT. THE CUSTOMER STATED THIS DELAYED THE TREATMENT OF A UTI UNTIL REPEAT TESTING RESULTS WERE OBTAINED THAT SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17729779 ↗MalfunctionMar 28, 2023Smoking; Smoking
CUSTOMER REPORTED VISIBLE SMOKE WAS OBSERVED UPON PLUGGING THEIR CLINITEK STATUS+ ANALYZER INTO THE POWER SOURCE. THE CUSTOMER IMMEDIATELY UNPLUGGED THE INSTRUMENT AND THERE WERE NO FURTHER ISSUES THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632165 ↗MalfunctionDec 22, 2022Low Test Results; Low Test Results
THE CUSTOMER REPORTED THAT THEY RECEIVED SEVERAL DISCREPANT LEUKOCYTE AND NITRITE RESULTS ON FOUR PATIENTS COMPARED TO RETESTING OF DIFFERENT SAMPLES ON A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16034006 ↗MalfunctionDec 21, 2022False Negative Result; False Negative Result
CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULT COMPARED TO AN ULTRASOUND AND RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16024054 ↗MalfunctionDec 8, 2022Smoking; Smoking
THE CUSTOMER REPORTED THEIR CLINITEK STATUS+ INSTRUMENT BEGAN TO SMOKE AFTER TWO FAILED ATTEMPTS TO POWER ON. THE INSUTRMENT WAS IMMEDIATELY UNPLUGGED. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15945677 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091216. One submission often covers many models, so check the product and lot details in each record.
- Z-0081-2015 · Sep 19, 2014 · TerminatedExternal power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
- Z-0082-2015 · Sep 19, 2014 · TerminatedExternal power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
- Z-0083-2015 · Sep 19, 2014 · TerminatedExternal power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
- Z-1545-2014 · Feb 26, 2013 · TerminatedCLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Other ENZYMATIC METHOD, CREATININE devices
- ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic) 10335869Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall24 reports
- Dimension Vista® Flex® reagent cartridge ECREA 10700444Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall10 reports
- Atellica CH ECre_2 11097533Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall6 reports
- VITROS 6802584Ortho-Clinical Diagnostics, Inc. · ENZYMATIC METHOD, CREATININE52 reports
- Dimension® Flex® reagent cartridge EZCR 10471520Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, CREATININE1 recall1 report
- Afinion HbA1c 1116974Abbott Diagnostics Technologies AS · Enzymatic Method, Creatinine1 recall0 reports
- Creatinine plus ver2 5168589190Roche Diagnostics GmbH · ENZYMATIC METHOD, CREATININE27 reports
- Creatinine plus ver2 3263991190Roche Diagnostics GmbH · ENZYMATIC METHOD, CREATININE25 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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