N/A 341098Recalls & reported problems
Becton, Dickinson And Company · BD® Anti-Kappa (TB28-2) APC · Class 1
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 25, 2022Open, Classified
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Z-1214-2022 · Root cause: Process control · FDA record ↗
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- Kreatech FISH probes 40V016V495Leica Biosystems Newcastle Ltd · Reagents, specific, analyte1 recall0 reports
- N/A 346587Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- CytoCell LPS508-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
- Vysis 05J70-001Abbott Molecular Inc. · REAGENTS,SPECIFIC,ANALYTE1 report
- N/A 641406Becton, Dickinson And Company · Reagents, specific, analyte1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.