Medical device manufacturer, Biomerieux, has issued a field safety notice concerning API LISTERIA 10STRIPS+10MEDIA with reference number 10300 and lot number 1003256440.
The manufacturer's internal investigation identified that the toxic logo label (Skull Sticker) is absent from the secondary packaging of the API LISTERIA 10STRIPS+10MEDIA kit (REF 10300), lot. 1003256440. The indication of toxic product is written, however the symbol that represents "Toxic product" indication is absent from the label of the secondary packaging.
All components of the affected kit are correctly labeled on their primary packaging, in particular the ZYM B reagent ampules which are considered a toxic product. The instructions for use located inside the kit also specifies a toxic product is inside the box, and includes rules in terms of protective equipment in order handle the toxic product.
The manufacturer defined the described issue as a minor overall risk to health for use in Medical bacteriology or in Industry bacteriology. The referenced issue does not present a risk to health or safety for patients or users of the product.
When using the affected products, users are advised to be aware of the toxic product located in the kit and refer to the instructions for use when handling the associated toxic products.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 6 October 2014