Research and Diagnostic Systems 3D508Recalls & reported problems
Research And Diagnostic Systems, Inc. · CBC-3D: 6 x 2mL TriPack (2 Low, 2 Normal, 2 High) · Class 2
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- Nov 7, 2022Terminated
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
Z-0999-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Mixture, Hematology Quality Control devices
- BD Multi-Check 349704Becton, Dickinson And Company · Mixture, hematology quality control1 recall1 report
- BD Multi-Check 349703Becton, Dickinson And Company · Mixture, hematology quality control1 recall1 report
- Research and Diagnostic Systems D3D04Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D503RXResearch And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D501Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D507Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems 3D506USResearch And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 reports
- Research and Diagnostic Systems D3D02Research And Diagnostic Systems, Inc. · Mixture, Hematology Quality Control1 recall0 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 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