Events

Rappel de Mueller Hinton E Agar (MHE) Mueller Hinton Agar 10 Plates, MME Agar 90 20 Plates

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomerieux Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00878-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00878-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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.

Device

Mueller Hinton E Agar (MHE) Mueller Hinton Agar 10 Plates, MME Agar 90 20 Plates
  • Modèle / numéro de série
    Mueller Hinton E Agar (MHE)Mueller Hinton Agar 10 PlatesReference Number: 04091Lot 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 PlatesReference Number: 413822Lot Numbers: 1005476830, 1005560780 and 1005651860 ARTG Numbers: 201986 and 182081
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd