Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:25418
Brand Name:Radiometer ABL90Flex; ABL80Flex; ABL9 analysers
Model:Radiometer ABL90FLEX (393-090) and ABL90FLEX plus (393-092) blood gas analysers
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:Additional investigation at Radiometer has concluded that the worst-case tBil bias for blood samples from newborn babies is much smaller (~10x) than what has been measured for adult blood samples at equal tHb levels.
Consequently, the risk assessment for newborn babies is updated.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:16/3/2020
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