AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
FDA device recall Z-0788-03 · posted 2003-05-01 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
- Action taken
- A Device Correction Letter was sent to all AEROSET System customers on 2/24/2003 informing them of the issue and measure they must take to minimize the risk of occurrence.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 645 units
- Distribution
- Nationwide and to the following countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand
- Date initiated
- 2003-02-24
- Date posted
- 2003-05-01
- Date terminated
- 2004-10-28
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |