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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01139-1
Product Name/Description Non Buffered Formalin. An in vitro diagnostic medical device (IVD)

Lot Numbers: 1507197760 and 1510204500

ARTG Number: 244174
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 19/11/2015
Responsible Entity Thermo Fisher Scientific Australia Pty Ltd
Reason/Issue Investigations have confirmed that certain lots of Non Buffered Formalin have had incorrect labelling placed on the bottles. The bottles have been labelled as 10% Neutral buffered formalin, rather than Non buffered formalin. This issue is unlikely to cause adverse health consequences.
Recall Action Recall
Recall Action Instructions Thermo Fisher is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 18/08/2016.
Contact Information 02 8817 4279 - Thermo Fisher