Abbott Laboratories, Inc AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
All Serial Numbers
Products Sold
All Serial Numbers
Abbott Laboratories, Inc is recalling AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irvi due to Change of level 3 error log messages to level 1 to prevent suspect assay results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Change of level 3 error log messages to level 1 to prevent suspect assay results.
Recommended Action
Per FDA guidance
The recall was initiated by letter on March 22, 2004. The letter instructed customers regarding steps to change the error levels on each AEROSET system.
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