Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19409
Brand Name:HemoCue HbA1c 501 Test Cartridge
Model:504110
Affected:F14K12K21DL
Software version:
Recalling Organisation:Radiometer Pacific
Suite 1
1/30 Benedicts Street
Eden Terrace
Auckland 1010
Contact Information:0800 723 722
Manufacturer:Hemocue AB
Issue:The manufacturer has identified that some of the HbA1c501 test cartridges, lot F14K12K21DL, may give elevated results.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:20/11/2015
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