Recall Z-0091-04 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Laboratories, Inc
AEROSET System Software version 1.02ER000
| Date | Jul 20, 2004 (initiated Sep 30, 2003) |
| Status | Terminated |
| Reason | Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. |
| Root cause | Other |
| Action | The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software. |
| Quantity | 133 |
| Distribution | Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |