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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00369-1
Product Name/Description	BD SARS-CoV-2 Reagents for BD MAX Systems. An in vitro diagnostic medical device (IVD). Catalog Number: 445003-01 Lot Number: 3291356 ARTG 334514 (Becton Dickinson Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/05/2024
Responsible Entity	Becton Dickinson Pty Ltd
Reason/Issue	One lot of the BD MAX SARS-CoV-2 assay may produce false negative results due to decreased activity of the enzyme utilised in the manufacture of this assay’s master mix. A review of all products produced with this master mix has been undertaken and no other assays are impacted. As a result of this problem, there is the potential for erroneous results, that could cause delayed or absent administration of anti-viral treatment in certain populations or increase the risk of unidentified disease progression. False negative results may also elongate unnecessary broad-spectrum empiric antibiotic therapy and diagnostic testing or increase the risk of viral transmission, especially in the case of asymptomatic patients.
Recall Action	Recall
Recall Action Instructions	Customers should immediately review inventory and dispose of any stock from the affected lot number. A credit will be issued for affected stock.
Contact Information	1800 656 100 - BD