CReactive Protein Gen3 4956842190Recalls & reported problems
Roche Diagnostics GmbH · 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 04015630923939), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (1 report).
1 other recall cover devices cleared under the same FDA submission (K083444); 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 18, 2026.
Most reported problems
Device problems
- Non Reproducible Results1
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.
MalfunctionApr 25, 2019Non Reproducible Results; Non Reproducible Results
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENT INVOLVED A TOTAL OF 3 PATIENTS WITH HIGH CRPL3 C-REACTIVE PROTEIN GEN.3 RESULTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8549746 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083444. One submission often covers many models, so check the product and lot details in each record.
- Z-0634-2021 · Nov 6, 2020 · TerminatedTina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinica
Other SYSTEM, TEST, C-REACTIVE PROTEIN devices
- Atellica CH Revised C-Reactive Protein (RCRP) 11537223Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, C-REACTIVE PROTEIN2 recalls0 reports
- Optilite C-Reactive Protein Reagent NK044.OPT.AThe Binding Site Group Limited · System, Test, C-Reactive Protein1 recall0 reports
- Tina-quant CReactive Protein IV 07876033190Roche Diagnostics GmbH · SYSTEM, TEST, C-REACTIVE PROTEIN7 reports
- Tina-quant CReactive Protein IV 07876424190Roche Diagnostics GmbH · SYSTEM, TEST, C-REACTIVE PROTEIN6 reports
- Dimension® Flex® reagent cartridge RCRP 10444903Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, C-REACTIVE PROTEIN6 reports
- Tina-quant C-Reactive Protein IV 08057591190Roche Diagnostics GmbH · SYSTEM, TEST, C-REACTIVE PROTEIN5 reports
- Tina-quant CReactive Protein IV 07876432190Roche Diagnostics GmbH · SYSTEM, TEST, C-REACTIVE PROTEIN3 reports
- CReactive Protein Latex) 20764930322Roche Diagnostics GmbH · SYSTEM, TEST, C-REACTIVE PROTEIN2 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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