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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01258-1
Product Name/Description	D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnostic medical device (IVD). Catalogue Number: 220-0201 Reorder Pack Lot Numbers: 2003022, 20030337, 64000331, 64000332, 64000888, 64001344, 64002239, 64002240 and 64002241 Floppy Diskette Lot Numbers: AA30324, AA30339, AA30545, AA31021 AA31023, AA31056, AA31097, AA31193, AA31194 and AA31195 CD-ROM Lot Numbers: BA31021, BA31023, BA31056, BA31097, BA31193, BA31194 and BA31195
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/12/2013
Responsible Entity	Bio-Rad Laboratories Pty Ltd
Reason/Issue	The cartridge injection counts not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Haemoglobin Testing System due to the incorrect configuration setting in the Update Kit disk.
Recall Action	Recall for Product Correction
Recall Action Instructions	As an interim measure, users are advised to manually track the number of injections on the cartridge and monitor the QC results throughout the life of the reorder pack. Bio-Rad is replacing the affected disks with a new update disk to be used with affected Reorder Packs.
Contact Information	1800 224 354 - Bio-Rad Laboratories