Recall Z-1142-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
| Date | Aug 21, 2003 (initiated Dec 29, 2000) |
| Status | Terminated |
| Reason | ICT assays run using a manual dilution will not be calculated correctly by the software. |
| Root cause | Other |
| Action | Product Information letter dated 29 December 2000 was sent to all AEROSET customers. |
| Quantity | 143 |
| Distribution | Nationwide and to the following countries: Brazil, Canada, Australia, New Zealand, Columbia, Venezuela, Argentina, Finland, France, Germany, Greece, Hong Kong, United Kingdom, Japan, Singapore, China, Italy, Ireland, Korea, Thailand, Turkey, Norway, India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |