Recall Z-0788-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
| Date | May 1, 2003 (initiated Feb 24, 2003) |
| Status | Terminated |
| Reason | Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride. |
| Root cause | Other |
| Action | A Device Correction Letter was sent to all AEROSET System customers on 2/24/2003 informing them of the issue and measure they must take to minimize the risk of occurrence. |
| Quantity | 645 units |
| Distribution | Nationwide and to the following countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |