Medical device manufacturer, Bio-Rad, has issued a medical device safety alert concerning its Coombs-Control IgG 1x10 ml [Product UDI: 16070; Catalogue Number: 109510; Lot Number: 399415062].
The manufacturer has been made aware that incorrect expiry dates are printed on the certificate of Analysis (CoA) and on the outer packaging labels of the affected product.
The incorrect expiry dates printed on the outer packaging labels and CoA are 2019-08-26, while the correct expiry date is in the inner packaging 2019-09-09. Therefore, the discrepancy is between the inner and the outer packaging.
According to the manufacturer, the situation does not present any risk for the users or patients the product can be use without restriction until the 9 September 2019.
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 26 July 2019