Recall Z-0846-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
| Date | Jul 20, 2004 (initiated Mar 22, 2004) |
| Status | Terminated |
| Reason | Change of level 3 error log messages to level 1 to prevent suspect assay results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 656 |
| Distribution | Nationwide and to the following foreign countries: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |