Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28973
Brand Name:Integrated Reaction Unit (IRU)
Model:
Affected:Lot Numbers 766233, 770433, 771200, 771201, and 773642 used with the Alinity m System.
Software version:
Recalling Organisation:Abbott Laboratories (NZ) Ltd
Unit D
4 Pacific Rise
Mt Wellington
Auckland 2025
Contact Information:0800 656 233
Manufacturer:Abbott Laboratories
Issue:The manufacturer has received complaints associated with the Alinity m Reaction Vessels (RVs) detaching from the RV Cap during transport by the pipettor robot. Customers reported finding RVs on the instrument deck, and Abbott has determined that an increase in the frequency of 1998 errors (Fluorescence signal evaluation did not meet expected criteria. Excessive noise was detected in the reference signal.) is associated with this issue.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:14/2/2022
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