Clinitek Atlas® 10 Reagent PAK for Urine Chemistry 10311120Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Clinitek Atlas® 10 Reagent PAK for Urine Chemistry for use with the Clinitek Atlas® Urine Chemistry Analyzer · Class 1
Data updated Oct 18, 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 00630414373003), received between Nov 18, 2016 and Nov 18, 2016.
The most frequently reported specific device problem is “False Negative Result” (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
- False Negative Result1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Nov 18, 2016False Negative Result; False Negative Result
CUSTOMER REPORTED 4 FALSE NEGATIVE LEUKOCYTES RESULTS ON THE INSTRUMENT WHEREAS ALTERNATE INSTRUMENT REPORTED MODERATE RESULTS FOR LEUKOCYTES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6113689 ↗
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- iQ200 Select/Elite Pro (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System3 recalls0 reports
- iQ200 Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System2 recalls4 reports
- iChem Velocity Back-Integrated Velocity (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System1 recall15 reports
- Aution™ Hybrid AU-4050 Chemical Analyzer 14603Arkray USA, Inc. · Automated Urinalysis System1 recall4 reports
- iChem Velocity Elite/Stand-Alone Velocity (NA)Beckman Coulter Ireland Inc. · Automated Urinalysis System1 recall0 reports
- UA Win10 Kit C52900Beckman Coulter Ireland Inc. · Automated Urinalysis System1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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