Recall Z-1341-04 ยท CGZ Electrode, Ion-Specific, Chloride
Abbott Laboratories, Inc
ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
| Date | Aug 13, 2004 (initiated Jun 10, 2004) |
| Status | Terminated |
| Reason | Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use. |
| Root cause | Other |
| Action | The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm representative. |
| Quantity | 171 units and 25 spare parts distributed |
| Distribution | Product was distrbued nationwide and to the following foreign countries: Mexico, Australia, Germany, Hong Kong, Canada, Thailand, Grand Cayman, Chile, New Zealand, Columbia, Brazil, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |