Recall Z-0173-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
| Date | Jul 20, 2004 (initiated Jun 6, 2002) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Phillippines, Brazil, Puerto Rico, Dominicam Republic, Canada, Germany, Taiwan, Thailand, Belgium, Egypt, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974651 | ABBOTT AXSYM SYSTEM Abbott Laboratories, Feb 12, 1998 |