AEROSET Analyzer
FDA Recall Z-0844-03 · Posted 2003-05-20
Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2002-08-15
Date Terminated2004-04-07
Product Quantity578
Reason for Recall
Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
Firm Action
The firm sent Technical Service Bulletins dated August 15, 2002 to consignees. Field Representatives are correcting the device in the field. A customer letter was released on August 20, 2002 to provide customers actions to take to prevent the occurrance.
Root Cause
Other
Distribution Pattern
Nationwide and to the following foreign countries: Mexico, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, New Zealand, and China
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.