Medical device manufacturer, Biomerieux, issued a medical device safety alert concerning its VIDAS Immuno-Assays [Multiple Products and Lots – Details please contact local supplier].

According to the manufacturer, a substrate error issue was confirmed on all lots of VIDAS Immuno-Assays manufactured with substrate batches using the common lot of raw material (4-MUP). The problem would prevent the test from being run, therefore leads to a potential delayed results as another test may be needed. The investigation by the manufacturer demonstrated that the issue occurs over the product shelf-life. For details, please refer to the customer letter issued by the manufacturer.

The manufacturer suggested the following corrective actions to affected users:

• For products with No remaining shelf life:
  • Identify impacted lots
  • Stop using the listed impacted lots
  • Destroy the remaining lots in user’s inventory.
• For products with remaining shelf life
  • Identify affected products
  • Update product expiry date per user’s internal procedures of the remaining usable lots to meet the new revised expiry date.
  • Continue product use until revised expiry date.
• Users are also advised to store all the VIDAS reagents at 2-8°C as described in Product Instructions for Use.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary action.

Posted on 29 Sept 2021