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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01315-1
Product Name/Description	BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens) BD BACTED FX - Top Unit Reference Number: 441385 Serial Numbers: FT2899, FT2914, FT2951 & FT3077 BD BACTEC FX - Bottom Unit Reference Number: 441386 Serial Numbers: FB1724 & FB1756
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/12/2013
Responsible Entity	Becton Dickinson Pty Ltd
Reason/Issue	BD has determined that some DB BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities. Specifically, the Anonymous vial indicator lights, which should appear yellow, may instead appear green in colour. This has the potential to lead a user of the instrument to accidentally discard an Anonymous vial or the readings associated with an Anonymous vial, before an anonymous vial has completed protocol. The affected instruments continue to function properly and will not report an incorrect result.
Recall Action	Recall for Product Correction
Recall Action Instructions	BD is providing a software update to correct the issue, which will be available in February 2014. As an interim measure, BD is providing users with work around instructions to follow until the software upgrade is completed.
Contact Information	02 8875 7165 - Becton Dickinson Service