Medical device manufacturer, BB Diagnostic Systems, has initiated a field safety corrective action concerning BD BBL Fildes Enrichment [Catalogue No.: 211866; Lot No.: 2079066, 2096375, 2216092, 2227271].
The manufacturer has determined through complaint investigation that the above-referenced lot numbers of product are failing to support the growth of Haemophilus species.
The affected users are advised to discontinue use and discard any remaining products. Due to an anticipated delay for the available of Fildes Enrichment, the manufacturer will substitute DIFCO Supplement B with Reconstituting Fluid (Catalogue no. 227610-6 x 10mL) as the replacement product.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 17 January 2013