Important Safety Alerts

Medical device manufacturer, BioMérieux, has issued a medical device safety alert concerning its VIDAS FSH. The affected products are identified as below:

• Product references: A) 30407; B) 30407-01.
• Lot numbers: A) 1005888220, 1006006370, 1006080890, 1006094700 and 1006214640; B) 1005888210.

The manufacturer has received several complaints for invalid calibration with low calibrator S1 while using VIDAS FSH reference 30407 / 30407-01. Tests performed in-house confirmed a decrease of the strips signal overtime for the impacted lots.

According to the manufacturer, the defect was highlighted with complaints for invalid calibration, but concerns all testing performed (calibration and patient's samples testing). The investigation concluded that this could have an impact on patient results. There are two possible situations as following:

1. In case of invalid calibration: an error message appears and it will not be possible to perform further testing with the concerned lot. In this context, the risk for patients is a delayed result due to invalid calibration.
2. In case of valid calibration: false results (falsely overestimated or falsely underestimated results) may happen.

Affected users are requested to destroy the impacted lots. For tests previously performed using the impacted lots of VIDAS FSH, the affected users are asked to discuss any concerns they may have regarding previously reported patient results obtained with the Clinicians to determine the appropriate course of action. Results should be reviewed and interpreted within the overall clinical context.

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 9 March 2018