Recall Z-0796-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AEROSET System External Waste Pump
| Date | May 9, 2003 (initiated Jan 27, 2003) |
| Status | Terminated |
| Reason | External waste pump has metal edge around perimeter sharp enough to cause scratch or cut. |
| Root cause | Other |
| Action | Firm sent 01/27/2003 letter to all consingees informing them of the issue. US Cutomer Reply form will be distributed with the customer letter. |
| Quantity | 461 units |
| Distribution | Nationwide and to the following foreign countries: Mexico, Chilie, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zealand, Malaysia, Japan, Taiwan, Korea, Singapore, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |