Reason/Issue |
Abbott has identified a problem related to cracks developing in an internal component (pump housing) of the Afinion 2 Analyser within a subset of serial numbers. Specifically, the serial numbers AF20052000 - AF20060000.
If the problem occurs, the user will experience frequent information codes. Specifically:
- Information codes 214 or 215 when running Afinion HbA1c, Afinion ACR or Afinion Lipid Panel - Information Code 302 when running Afinion CRP assays.
No results would be obtained, and in turn, there would be a potential delay of treatment. Upon assessment, there is no health hazard associated with this problem and therefore no identifiable or potential adverse health consequence associated with the use of, or exposure to the instrument. There is no impact to patient management. Failsafe mechanisms are built into the instrument to prevent erroneous results. |