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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00280-1
Product Name/Description D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)

Catalogue Number: 220-0220
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/03/2014
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue On a rare occasion, the D-10 software might generate an extra result by duplicating the result from the previous sample and the Sample ID/Injection # from the next sample. The duplicate is readily detectable when sorting the Daily Summary by the injection # and reviewing for duplication of the same sample ID number. Such duplication could potentially lead to discrepant sample results, which should not be reported.
Recall Action Recall for Product Correction
Recall Action Instructions Bio-Rad are providing users with work around instructions to follow as an interim measure. Bio-Rad will release a permanent solution when available. This action has been clsoed-out on 18/02/2016.
Contact Information 1800 224 354 - Bio-Rad Tech Support