Medical device manufacturer, bioMerieux, has issued a medical device safety alert concerning its VIDAS Varicella-Zoster IgG (VZG) [Reference Number: 30217; Batch: 1007410330 and 1007393380; Expiry Date: 8 February 2020].

Following customers complaints for invalid calibration when using one kit of the affected product (Batch 1007410330), the investigation was initiated. The tests confirmed the invalid calibration on the customer's kit with an increase of the Calibrator S1 signal. The tests performed internally showed a signal heterogeneity within the lot of Solid Phase Receptacle included in the kits VIDAS VZG batches 1007410330 and 1007393380. The root cause has not been identified yet, the investigation is still on-going.

According to the manufacturer, affected users could observed two situations:

• If the calibration is invalid, they would have an alert on the VIDAS instrument. The impact of the issue is a delayed result on patient's sample.
• If the calibration is valid; the risk is to have VZG false positive result on samples.

The affected users are requested to take the following actions:

• Stop using the affected products and destroy the remaining products.
• Discuss any concerns may have regarding previously reported patient results obtained with the Laboratory Medical Director to determine the appropriate course of action. Results should be reviewed and interpreted in the context of the overall clinical picture. Assess the need for retesting in case of patients at risk after Varicella Zoster virus contact.
• Contact the local customer service if they have observed the issue and have a doubt regarding their results.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 4 December 2019