Abbott Laboratories, Inc AEROSET System Software version 1.02ER000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AEROSET System Software version 1.02ER000
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog 2-95068-01 AEROSET System Software 1.02ER000 and Catalog 2-95175-01 AEROSET System Software 1.02ER000 Upgrade Kit
Abbott Laboratories, Inc is recalling AEROSET System Software version 1.02ER000 due to Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
Recommended Action
Per FDA guidance
The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026