Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
FDA device recall Z-1142-03 · posted 2003-08-21 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- ICT assays run using a manual dilution will not be calculated correctly by the software.
- Action taken
- Product Information letter dated 29 December 2000 was sent to all AEROSET customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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,
- Date initiated
- 2000-12-29
- Date posted
- 2003-08-21
- Date terminated
- 2003-08-20
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |