N/A 340936Recalls & reported problems
Becton, Dickinson And Company · BD® CD11b (D12) APC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Oct 25, 2023Open, Classified
In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.
Z-0641-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Reagents, specific, analyte devices
- N/A 340757Becton, Dickinson And Company · Reagents, specific, analyte1 recall1 report
- N/A 341098Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- CytoCell LPS508-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
- Kreatech FISH probes 40V016V495Leica Biosystems Newcastle Ltd · Reagents, specific, analyte1 recall0 reports
- N/A 346587Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- CytoCell LPS509-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
- N/A 347206Becton, Dickinson And Company · Reagents, specific, analyte1 report
- Vysis 05J82-001Abbott Molecular Inc. · REAGENTS,SPECIFIC,ANALYTE1 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 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