Important Safety Alerts

Medical device manufacturer, Bio-Rad, has issued a medical device safety alert concerning its ID-DiaCell I-II-III Asia. The affected devices are identified as follow:

• ID number: 45330
• Reference number: 003614
• IHD Batch numbers: 45330 52 1, 45330 52 2
• SAP Batch numbers: 375053521, 378425522

Further to customer's reports, the manufacturer has been able to confirm that the affected products shows a reduced reactivity against samples known to contain anti-Mi^a.

According to the manufacturer, this situation may potentially lead to false negative results with samples containing weak forms of anti-Mia antibody. The result could thereafter affect the blood compatibility analysis prior to transfusion as well as the assessment for the need to refer to foetal medicine specialist during the pregnancy.

Affected users are asked to take the following actions:

• Stop using the affected lots and destroy those not used yet.
• Use another lot number.
• Where deemed necessary by the medical director of the laboratory, patients tested with the affected products should be re-tested with another lot.

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 30 May 2019