Medical device manufacturer, BioMerieux, has issued a medical device safety alert concerning its VIDAS NT-proBNP2 [Reference: 30458; Lot Number: 1007078560; Expiry Date: 15 January 2020]
Following customers' complaints about error analysis during calibration, the manufacturer's investigation has confirmed an issue with this specific lot of the affected product on VIDAS PC instrument. The investigation confirmed that the calibration of the affected product cannot be performed on VIDAS PC instrument. At the end of the calibration analysis on the VIDAS PC, an error message "Error Analysis" is obtained. The tests performed during the investigation showed that the issue occurs only with the affected product when using VIDAS PC instrument. The issue does not occur when the affected product is used on the VIDAS 3 or on the MINI VIDAS instruments and on other lots of VIDAS NT-proBNP2 using any VIDAS system.
According to the manufacturer, as the calibration for the affected product cannot be performed on VIDAS PC instrument, it is not possible to obtain results of patients' samples. The main risk caused by this issue is a delayed result for the patient as the patient samples cannot be tested if calibration is invalid and if no other lot is available in the laboratory. There is also a risk of sample loss when calibration is launched concomitantly with sample testing. There is no risk of false result because the equipment cannot give any result as the calibration failed.
Affected customers are required to take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 23 May 2019