Medical device manufacturer, Biomerieux, has issued a field safety notice (FSN) concerning certain lots of Biomerieux FB (Fast blue BB) with reference number 70562, ZYM B reagent with reference number 70493, API Listeria with reference number 10300, and API NH with reference number 10400.

• Identification strips using the FB reagent: API Campy (20800), ID 32 Staph (32500), Rapid ID 32A (32300), Rapid ID 32 Strep (32600)
• Identification strips using the ZYM B reagent: API 20 Strep (20600), API Coryne (20900), API Staph (20500), API ZYM (25200), API NH (10400), API Listeria (10300)

The issue may result in misidentification of microorganisms.

The manufacturer advises users of the followings:

• If users are in possession of some kits of FB reagent (70562), they should implement the mandatory requirements as mentioned in the FSN.
• If users are in possession of some kits of ZYM B (70493), API NH (10400) and API Listeria (10300), they should check the aspect of ZYM B (70493) before each use and follow the recommendations mentioned in the FSN.
• Users should discuss with the Laboratory Director to evaluate the impact and determine if any retrospective analysis of results is required.

For the next batches, an insert will be added in FB reagent (70562), ZYM B (70493), API NH (10400) and API Listeria (10300) to explain the mandatory actions required in this FSN.

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 11 March 2014