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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