Abbott Diagnostics Division
FDA adverse event reports naming Abbott Diagnostics Division as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ABBOTT DIAGNOSTICS DIVISION.
- Total reports
- 4,193
- Deaths
- 4
- Injuries
- 41
- Malfunctions
- 4,147
Reports per year
Source: FDA adverse event reports by year received, 2006–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2010-11-29TerminatedProcess control
CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, CELL-DYN 4000 Vent Needle, List Number: 02H61-01, CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101, CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
The Vent Needle, which is built into the Vent Head Assembly on the CELL-DYN Sapphire Instrument and which is used directly on the CELL-DYN 4000 Instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample.
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