CLINITEK Status®+ Analyzer 10379677Recalls & 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 1
All models of CLINITEK Status+ Analyzer (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414572314), received between Dec 5, 2018 and Dec 5, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2018False Negative Result; False Negative Result
THE CUSTOMER REPORTED THREE PATIENTS WITH FALSE NEGATIVE AND ONE PATIENT WITH SMALL LEUKOCYTE RESULTS ON THE CLINITEK STATUS+ WHEN COMPARED TO THE MANUAL MICROSCOPY READING. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8135618 ↗
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 DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) devices
- Medline MPHUA10SGMedline Industries, Inc. · DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)4 reports
- CHEMSTRIP 10 UA TEST STRIPS 11895354160Roche Diagnostics GmbH · DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)2 reports
- Chemstrip 7 Test Strips 11008552160Roche Diagnostics GmbH · DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)2 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 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