Recall Z-0725-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02
| Date | Apr 16, 2003 (initiated Feb 24, 2003) |
| Status | Terminated |
| Reason | Under certain operating conditions, smart wash feature disables with multiple samples. |
| Root cause | Other |
| Action | A device correction letter was sent 02/24/2003 to all AEROSET customers with a US Customer Reply Form. A Technical Service Bulletin will be released to include the Device Correction letter and instructions for Field Service Personnel. A Quality Directive will be issued to provide instructions to Customer Service. |
| Quantity | 645 units |
| Distribution | Nationwide and to Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, and New Zeland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |