Important Safety Alerts

Medical device manufacturer, Bio-Rad Laboratories, has issued a medical device safety alert concerning its Assayed VIROTROL II-B and VIROTROL II. The affected products are identified as follow:

• Assayed VIROTROL II-B [Catalogue Number: 00152; Lot Number: 103080; Expiration Date: 30 July 2020; UDI Number: 00847661002871]
• VIROTROL II [Catalogue Number: A) 00115B, B) 00104B; Lot Number: A) 122610, B) 123600; Expiration Date: A) 30 June 2020, B) 30 May 2020; UDI Number: A) 00847661005629, B) 0084766100506]

The affected products are intended for use as reactive quality controls with in vitro assay procedures for determination of antibodies to HBsAg (anti-HBs) and antibodies to HAV (anti-HAV). The manufacturer has recently confirmed non-reactive results when using the affected product lots. Due to this issue, the manufacturer recommends affected users to immediately discontinue use of the affected product lots.

Affected users should discard all remaining inventory of the affected product lots. Product replacement is on-going.

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 6 March 2020