Medline MPHUA10SGRecalls & reported problems
Medline Industries, Inc. · STRIPS,URINE,REAGENT,10SG,100 STRIPS/BT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884389181911), received between Mar 3, 2025 and Sep 29, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “False Positive 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result3
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936719 ↗MalfunctionSep 21, 2026False Positive Result
This summary report covers malfunction events that occurred between July 1 and September 30, 2023. This VMSR summarizes one malfunction event involving two bottles of Medline urine reagent strips (catalog number MPHUA10SG). The account reported that the strips produced a false-positive result. No physical samples, photographs, videos, or requested additional information were received; therefore, the reported malfunction could not be confirmed and the cause was not established. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846157 ↗MalfunctionSep 2, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50574366 ↗InjuryMar 3, 2025False Negative Result; False Negative Result
ACCORDING TO THE FACILITY, "ON (B)(6) 2025, 67 Y/O FEMALE INTO THE OFFICE WITH C/O OF URINARY TRACT INFECTION SIGNS AND SYMPTOMS. PATIENT DENIED ANY FEVER BUT WAS C/O PAIN UPON URINATION, BLOOD IN URINE AND STRONG ODOR TO HER URINE. A URINE DIP WAS COMPLETED USING THE URINE REAGENT 10SG 100 STRIPS/BT, WITH THE REF# MPHUA10SG, LOT # 98124030001, WITH EXPIRATION DATE OF 04/10/2026. THE DIP SHOWED POSITIVE FOR BLOOD, PROTEIN AND KETONES. ALL OTHER RESULTS ON STRIP WERE NEGATIVE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21510398 ↗
Other DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) devices
- 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
- CLINITEK Status®+ Analyzer 10379677Siemens Healthcare Diagnostics Inc. · DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)1 report
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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