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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00794-1
Product Name/Description	BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD) Reference Number: 279045 Lot Number: 1048256 ARTG Number: 194228
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/06/2017
Responsible Entity	Biomerieux Australia Pty Ltd
Reason/Issue	BioMérieux has become aware of a crimp defect associated with the BacT/ALERT BPN culture bottles. An anomaly was identified during the manufacturing process that may lead to having excess material at the neck of the bottle. This material may separate from the crimp exposing a sharp edge or causing a minor cut hazard.
Recall Action	Recall
Recall Action Instructions	Customers are requested to: - Confirm this letter has been distributed to and reviewed by all appropriate personnel within the organisation. - Review inventory of BacT/ALERT BPN bottles for Lot Number 1048256 and discard all affected bottles from this lot. Please store this letter with your bioMerieux instrument documentation. This action has been closed out on the 16/11/2018.
Contact Information	1800 333 421 - bioMérieux Help Desk Department