BD Rapis Diagnostics (suzhou) Co. Ltd.
FDA adverse event reports naming BD Rapis Diagnostics (suzhou) Co. Ltd. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD..
- Total reports
- 2,272
- Deaths
- 1
- Injuries
- 66
- Malfunctions
- 2,205
Reports per year
216
217
3518
25319
49220
57121
20122
15923
9124
32725
13926
Source: FDA adverse event reports by year received, 2016–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Coronavirus Antigen Detection Test System.QKP832
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ395
- Antigens, All Groups, Streptococcus Spp.GTY235
- Covid-19 Multi-Analyte Antigen DeviceQMN235
- Antigens, Cf (Including Cf Control), Influenza Virus A, B, CGNX192
- Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA164
- Devices Detecting Influenza A, B, And C Virus AntigensPSZ143
- Needle, Hypodermic, Single LumenFMI25
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG15
- Set, Administration, IntravascularFPA11
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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