Medical device manufacturer, Bio-Rad, has issued a medical device safety alert concerning its DC-Screening II [ID Number: 50560; Reference Numbers: 004831, 004836, 004837; IHD Batch Numbers: 50560 94 01, 50560 94 02, 50560 94 03; SAP Batch Number: 3118949401, 3243879402, 3243909402, 3243939402, 3393449403].

Further to customer's reports, it has been able to confirm that the affected products show a reduced reactivity against samples known to contain red blood cells coated with low amounts of C3d (C3b).

According to the manufacturer, this situation may potentially lead to false negative results with samples containing red blood cells coated with low amounts of C3d/C3b only (no IgG). These results might be contradictory with the other data (laboratory/clinical) leading to further investigations; however, the final diagnosis and treatment do not rely only on the Direct Antiglobulin Testing (DAT) result.

Affected users are advised to take the following actions as immediate protective measures:

• Stop using the affected lots and destroy those not used yet;
• Use another lot number;
• The negative results obtained with the affected lots should be reassessed by the biologist and/or the clinician considering this information to determine whether further actions are required depending on the clinical context.

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 products, please contact your supplier for necessary actions.

Posted on 13 September 2019