Optilite C-Reactive Protein Reagent NK044.OPT.ARecalls & reported problems
The Binding Site Group Limited · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Feb 19, 2019Class IITerminated
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Z-0671-2020 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
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
- 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
- CReactive Protein Gen3 4956842190Roche Diagnostics GmbH · SYSTEM, TEST, C-REACTIVE 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page