Medical device manufacturer, Ortho Clinical Diagnostics, has issued a medical device safety alert concerning its VIITROS Immunodiagnostic Products NT-proBNP Calibrators (Product Code 6802157; Lot 1110) and VITROS Immunodiagnostic Products NT-proBNP Reagent Packs (Product Code 6802156; Lot 1110).
During routine internal testing, the manufacturer identified potential for non-reproducible, higher than expected results that may exceed the decision thresholds for congestive heart failure (CHF) when using VITROS NT-proBNP Reagent Packs, Lot 1110. When using the affected lots of products, elevated results were observed across the measuring range of the assay (5.00 to 35,000 pg/mL and 0.590 to 4130 pmol/L). Analysis determined that this issue may affect approximately 1 in 73 test results, or 1.37%.
The manufacturer advises affected users to take the following actions:-
According to the manufacturer, the affected products were not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 08 April 2014