Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00582-2
Product Name/Description	BD MAX Instruments. An in vitro diagnostic medical device (IVD) Catalogue number: 441916 Serial numbers: CT0182, CT0213 & CT0174
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/06/2013
Responsible Entity	Becton Dickinson Pty Ltd
Reason/Issue	BD has determined during instrument testing a small portion of instruments were built with the wrong power module component, which is rated 1 Amp instead of the required 10 Amp. BD has advised that the user would not be aware of this defect, as the instrument will function as expected, with no impact on specimen processing or results reporting. However, the component inside the instrument will get hot, and over time the component will fail, which could cause downtime and require a service visit. The BD Max instrument operates with a current between 1.3 and 3 Amps. In assessing the potential impact of installing a 1 versus 10 Amp power input module, the manufacturer ran the 1 Amp power input module at various current levels and measured the temperature of the component, with the following results: 1.9 A for 14 minutes – 45°C 3.3 A for 20 minutes – 66°C 4.4 A for 14 minutes – 80°C.   The component is rated by its manufacturer for use up to 85°C.
Recall Action	Recall for Product Correction
Recall Action Instructions	A BD service representative will correct affected systems on-site after undertaking a system check to determine if there are any affected systems in the field.
Contact Information	02 8875 7000 - Becton Dickinson