Recall Z-0016-05 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AEROSET Analyzer, Systems Operation Manual.
| Date | Oct 9, 2004 (initiated Sep 24, 2004) |
| Status | Terminated |
| Reason | Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified. |
| Root cause | Other |
| Action | The recall was initiated by Device Correction Letter to all AEROSET customers. The Device Correction Letter will be provided to new customers until the new revision of the Operations Manual. |
| Quantity | 835 units |
| Distribution | Nationwide and to: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |