ADVIA® Chemistry TP Total Protein II Reagents 10311878Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Total Protein - ADVIA Chem. - RGT - 4x850/4x700 tests · 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 00630414465227), received between Jan 11, 2019 and Jan 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (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
- Off-Label Use1
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.
MalfunctionJan 11, 2019Off-Label Use; Off-Label Use
LOW TOTAL PROTEIN RESULTS WERE OBTAINED WITH THE ADVIA CHEMISTRY TOTAL PROTEIN II REAGENT. THE CUSTOMER WAS USING EXPIRED CALIBRATOR MATERIALS FOR TESTING. NO DATA HAS BEEN PROVIDED BY THE CUSTOMER. THE CUSTOMER STATED THAT NO RESULTS WERE QUESTIONED. THERE ARE NO KNOWN REPORTS OF ANY IMPACT TO PATIENTS DUE TO THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8240498 ↗
Other BIURET (COLORIMETRIC), TOTAL PROTEIN devices
- Atellica CH UCFP 11097543Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN2 recalls19 reports
- ADVIA Chemistry UCFP 11319151Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN2 recalls10 reports
- Atellica™ CH TP 11097604Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN1 recall0 reports
- VITROS 8392292Ortho-Clinical Diagnostics, Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN1 recall0 reports
- Total Protein Gen.2 08058652190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN13 reports
- Total Protein Gen2 3183734190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN11 reports
- Total Protein Gen2 5171385190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN5 reports
- Atellica CH UPro 11097524Siemens Healthcare Diagnostics Inc. · BIURET (COLORIMETRIC), TOTAL PROTEIN1 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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