Abbott Diagnostics (Abbott) has issued an urgent product recall on Clinical Chemistry Alkaline Phosphatase reagent lots 71628UN10, 62474UN10, and 08145UN11, due to particulate matter in some reagent cartridges, which has been identified as a Cladosporium fungal species. According to Abbott, the fungus does not represent a hazard, but appears to generate visible clumps within the reagent cartridge, and may cause discoloration over time.
Abbott supplemented that they have not received reports of inaccurate Alkaline Phosphatase results due to this issue, nor has internal testing demonstrated any impact to results; however, having confirmed the error codes on calibration and sample runs, internal data suggests a rare (0.00636%) potential for inaccurate results to exist.
The supplier suggests that, if you are using or have inventory of Clinical Chemistry Alkaline Phosphatase (LN 7D55-21 lot 71628UN10, or LN 7D55-31 lot 62474UN10 and/or lot 08145UN11), you should discontinue use and destroy any remaining inventory of those lots in accordance with your institution's policies and procedures.
According to the local supplier, the affected products have been distributed in laboratories in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.