The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
FDA device recall Z-0274-04 · posted 2003-12-25 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
- Action taken
- All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 17,850
- Distribution
- Worldwide
- Date initiated
- 2003-10-29
- Date posted
- 2003-12-25
- Date terminated
- 2007-11-13
- Location
- Irving, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AXSYM SYSTEM (K974651) | Abbott Laboratories | 1998-02-12 |