| 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 |
|
| 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 |