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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00386-1
Product Name/Description MV1031 Gram Crystal Violet 4L. An in vitro diagnostic medical device (IVD)

Lot Number: 1339353
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 5/05/2015
Responsible Entity Thermo Fisher Scientific Australia & New Zealand
Reason/Issue Investigations have confirmed that this batch of Gram Crystal Violet may be contaminated with an environmental Gram-negative bacillus. Continued use of this batch may result in an appearance that those cultures being stained include a Gram-negative rod, or that otherwise sterile samples may contain this organism.
Recall Action Recall
Recall Action Instructions Laboratories are requested to cease use and discard the affected lot of Gram Crystal Violet. This action has been closed-out on 03/03/2016.
Contact Information 08 8238 9044 - Thermo Fisher Scientific