Recall Z-0421-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
| Date | Jan 11, 2003 (initiated Dec 18, 2002) |
| Status | Terminated |
| Reason | Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close. |
| Root cause | Other |
| Action | Abbott Laboratories sent a December 18, 2002 letter to all consignees informing consignees of their plans to install a locking mechanism on all AxSYM Systems. The installations will be performed by Abbott Representatives. A customer reply form was included in the device correction letter. |
| Quantity | 18,832 units |
| Distribution | Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Canada, Germany, Ireland, England, Belgium, France, Austria, Italy, Spain, Russia, Japan, Singapore, Hong Kong, Taiwan, Thaila |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974651 | ABBOTT AXSYM SYSTEM Abbott Laboratories, Feb 12, 1998 |