The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
This recall has been terminated (originally issued December 25, 2003).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- October 29, 2003
- Posted
- December 25, 2003
- Terminated
- November 13, 2007
- Recall Number
- Z-0274-04
- Quantity
- 17,850
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
Distribution
Worldwide
Lot / Code Info
Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers
Root Cause
Other
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.
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