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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00878-1
Product Name/Description	Mueller Hinton E Agar (MHE) Mueller Hinton Agar 10 Plates Reference Number: 04091 Lot Numbers: HDL-301, HDQ-022, HDT-322, HDT-315, HE2-119, HE2-112, HE3-205, HE5-403, HE8-003, HEA-208, HEA-201, HEC-406, HEG-101, HEJ-301, HEK-403, HDC-201 and HDQ-012 MME Agar 90 20 Plates Reference Number: 413822 Lot Numbers: 1005476830, 1005560780 and 1005651860 ARTG Numbers: 201986 and 182081
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/07/2017
Responsible Entity	Biomerieux Australia Pty Ltd
Reason/Issue	bioMérieux received a customer complaint regarding QC failures (diameter out of range - too high) when testing ATCC strains for antibiotic susceptibility test by disk diffusion method when using MHE agar. It could be determined that the use of the medium MHE by disk diffusion method with the antibiotics belonging to cyclines and aminosides classes could potentially lead to failure to quality control test (out of range high) and false susceptible result for clinical isolates (whatever the strain that could be tested) instead of resistant results. As a result there is a potential performance issue on strain categorisation that could lead to False Susceptible Result for antibiotics belonging to cyclines and aminosides classes when testing patients’ samples’ for antibiotic susceptibility test by disk method using specific lots of MHE agar.
Recall Action	Recall
Recall Action Instructions	bioMérieux is requesting customers: 1. Distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred our product; 2. Laboratories should stop using the specific lots of MHE agar ref. 04091, 413822 , segregate the product and discard/ dispose appropriately under laboratory guidelines; 3. Among tests previously performed, identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant; 4. Complete and return the acknowledgement form to qa.anz@biomerieux.com to confirm receipt; and 5. Contact your local bioMérieux representative for product compensation if needed. This action has been closed out on 04/03/2019
Contact Information	1800 333 421 - bioMérieux Help Desk