Print version of this report
TGA Action ID RC-2025-RN-00421-1
Type of Product Medical Device
Product Name/Description AU480 and AU680 Clinical Chemistry Analysers. An in vitro diagnostic medical device (IVD).

Multiple REF numbers

Serial Numbers AU480: From 10155 to 2025021482

Serial Numbers AU680: From 10436 to 2022087656
ARTG Number 177999
Unique Device Identifier (UDI) MU993400 04987666522939
Action Type Recall
Action Level Hospital
Hazard Classification Class II
Reason for the Action Beckman Coulter has identified that when using MU993400 sample probes with lot numbers from 178713114 to 179433670 on AU480 and AU680 clinical chemistry analysers, there is remote probability of false low test results due to sample dispensing problems.
Instructions for Customers/Users Customers should:
• Check the analysers, which meet the condition below, as they may include a defective sample probe.
o Analysers whose Serial No. is from 2023070718 to 2025021482.
o Analysers whose sample probe has been replaced since July 1, 2023.
• For analysers that meet either of the above criteria, remove the sample probe from the instrument in accordance with IFU Section 6, Maintenance / As needed Maintenance/Replace a Sample or Reagent Probe.

And then, check the groove on the head of the removed sample probe.
? If it has “a marking line”, please continue to use.
? If it does not have “a marking line”, please replace the sample probe with a probe not included in the impacted sample probe LOT numbers.
NB: If all the results of the actions above show only defective sample probes on their analysers and in stock, stop measuring the assay items which sample volume is 2.0 uL or less and contact your BEC representative for a replacement.

This action has been finalised on 12/09/2025.
Action Commencement Date 1/05/2025
Responsible Entity Beckman Coulter Australia Pty Ltd
Contact Information 1800 060 881 - Customer Support Centre