Albustix® Reagent Strips 10333485Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine. · Class 2
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 00630414550602), received between Mar 1, 2021 and Mar 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (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
- Non Reproducible Results1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2021Non Reproducible Results; Non Reproducible Results
A PHARMACIST REPORTED THAT A PATIENT TESTED THEIR MORNING URINE SAMPLE WITH TWO DIFFERENT LOTS OF ALBUSTIX FOR PROTEIN AND THE RESULTS WERE NEGATIVE. LATER THAT AFTERNOON, THE PATIENT HAD A NEW URINE SAMPLE RUN IN THE LABORATORY AND THE PROTEIN RESULT WAS 2+. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11396276 ↗
Other METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) devices
- cobas u pack 06334601001Roche Diagnostics GmbH · METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)1 recall1 report
- Chemstrip 10 MD Test Strips 3260763160Roche Diagnostics GmbH · METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)23 reports
- CHEMSTRIP 2 GP URINE TEST STRIPS 11895362160Roche Diagnostics GmbH · METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)3 reports
- KETO-DIASTIX® 2883Ascensia Diabetes Care US Inc. · Method, Enzymatic, Glucose (Urinary, Non-Quantitative)2 reports
- Medline MPHUA120MMedline Industries, Inc. · METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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