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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00995-1
Product Name/Description BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection instrument). An in-vitro diagnostic medical device (IVD)

Catalogue Number: 441916

Serial Numbers: CM0053 and CM0105
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/09/2012
Responsible Entity Becton Dickinson Pty Ltd
Reason/Issue BD has determined that the BD MAX Instrument may have minor defects that could cause the instrument to malfunction yet is unlikely to cause erroneous results. The minor defect(s) may be due to the following:
1) A potential misalignment of the filters/lens in the Reader assembly that can produce reaction curves with excess variability
2) A supplier defect on a limited number of Mux Heater Board assemblies
Recall Action Recall for Product Correction
Recall Action Instructions Becton Dickinson Service Associate to inspect the instrument and perform corrections if required
Contact Information 02 8875 7201 - Becton Dickinson Regulatory Affairs