Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:23302
Brand Name:ABL800 series analysers
Model:All with software versions 6.14 through to Version 6.18
Affected:
Software version:
Recalling Organisation:Radiometer Pacific
Suite 1
1/30 Benedicts Street
Eden Terrace
Auckland 1010
Contact Information:0800 723 722
Manufacturer:Radiometer Medical ApS
Issue:In July 2018, the manufacturer advised that the ABL800 series analysers could potentially provide a mix-up of patient results when Confirmation of Demographics is enabled as part of the query to AQURE, Radiance, or a HIS LIS system. (Note: The default setting is that this function is disabled.) The manufacturer has since been working on a permanent solution which involved a redesign of the analyser software. The permanent countermeasure to this issue is now released in software version 6.18 MR1.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:23/5/2019
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /