BÜHLMANN Laboratories AG has issued a medical device safety alert concerning its CALEX Cap device [Catalogue number: B-CALEX-C50, B-CALEX-C200, B-CALEX-C500].
According to the manufacturer, a mean positive bias of 15.6 % has been confirmed for results obtained with stool extraction using the original CALEX Cap device in comparison to results obtained with the reference manual weighing and extraction method – 1:50 dilution.
Given the overall analytical and clinical performance of fecal calprotectin assays and the general imprecision level of stool extraction methods, the above mean bias of 15.6 % is considered to have limited impact on result interpretation.
The positive bias may, in few cases, lead or have led to the interpretation of calprotectin levels as elevated (> 200 μg/g), requiring further investigative and curative procedures. With stool specimen preparation using the reference manual extraction procedure, they would be determined as having a low inflammatory response thus repeating the measurement and performing further investigations would be recommended.
In few cases patients may be or may have been assigned as having a low inflammatory response (> 50μg/g), although, with stool specimen preparation using the reference manual extraction procedure, they would be determined as having normal calprotectin values.
Affected users are advised to the take the following actions:-
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 March 2017