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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00353-1
Product Name/Description Horse Blood Agar. An in vitro diagnostic medical device (IVD)

Reference Number: 04059

Lot Number: JCU-203

ARTG Number: :201986
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 2/05/2018
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue bioMérieux has identified an issue at their Brisbane Culture Media manufacturing site regarding product reference number 04059, lot number JCU-203, Horse Blood Agar. During post release testing a potential contamination issue (contaminated deep and surface) has been identified. The microorganism was identified as a gram positive bacilli.
Recall Action Recall
Recall Action Instructions bioMérieux is requesting that Laboratories should:

1.Stop using HBA ref. 04059, Lot JCU-203 and segregate the product and discard/dispose appropriately under the relevant laboratory guidelines;
2.Complete and return Attachment A from the customer letter to in order to confirm receipt; and
3.Contact your local bioMérieux representative for product compensation as necessary.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 02 8852 4700 - bioMérieux