Recall Z-0844-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AEROSET Analyzer
| Date | May 20, 2003 (initiated Aug 15, 2002) |
| Status | Terminated |
| Reason | Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste. |
| Root cause | Other |
| Action | The firm sent Technical Service Bulletins dated August 15, 2002 to consignees. Field Representatives are correcting the device in the field. A customer letter was released on August 20, 2002 to provide customers actions to take to prevent the occurrance. |
| Quantity | 578 |
| Distribution | Nationwide and to the following foreign countries: Mexico, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, 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 |