AEROSET Analyzer
FDA device recall Z-0844-03 · posted 2003-05-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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
- Date initiated
- 2002-08-15
- Date posted
- 2003-05-20
- Date terminated
- 2004-04-07
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |