AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
FDA device recall Z-0173-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.
- Action taken
- All consignees received Technical Service Bulletin (TSB) #83-081. This TSB gave instructions on how to install the AxSYM Small Heater Block clamp upgrade implemented June 6, 2002.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 15437 units worldwide
- Distribution
- Nationwide and to the following foreign locations: Mexico, Viet Nam, Venezuela, Columbia, Argentina, Chile, Japan, Austria, Denmark, France, Israel, Norway, Saudi Arabia, Spain, Turkey, India, Phillip
- Date initiated
- 2002-06-06
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-09
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AXSYM SYSTEM (K974651) | Abbott Laboratories | 1998-02-12 |