Aeroset Analyzer, item 9D05-01
FDA Recall Z-0843-03 · Posted 2003-05-20
Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2001-10-02
Date Terminated2004-04-07
Product Quantity238 units
Reason for Recall
Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
Firm Action
The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
Root Cause
Other
Distribution Pattern
Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.