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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00433-1
Product Name/Description	Afinion 2 Analyser. An in vitro diagnostic medical device (IVD) Part number: 1116770 Serial number: AF20052000 to AF20060000 UDI: 7070060014418 ARTG 204479 (Abbott Rapid Diagnostics Pty Ltd T/A Alere - Instrument/analyser IVDs)
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	30/05/2024
Responsible Entity	Abbott Rapid Diagnostics Pty Ltd
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.
Recall Action	Product Defect Correction
Recall Action Instructions	If users have an instrument in the affected serial number range a replacement will be processed.
Contact Information	1800 622 642 - Customer Support