Medical device manufacturer, SSI Diagnostica A/S, has issued a medical device safety alert concerning its Pneumococcus factor 7 antiserum [Item no.: 16931; Lot no.: C7F17X1; C7F17U1].
According to the manufacturer, on the basis of a customer's complaint concerning a weak reaction when serotyping using the Lot C7F17X1. The manufacturer checked the original quality control of the lot that the product performed as expected, when released.
By performing further tests of 4 additional lots from the same bulk showed that the factor sera were weakening over time for another lot (C7F17U1) as well. It is difficult to distinguish between positive and negative reactions. The users will not be able to sub serotype pneumococcus group 7, but it will have no effect on the patient or the treatment of the patient. Since the product is for serotyping only and not for diagnostic use. Thus, there is no patient risk.
The manufacturer revised the Standard Operating Procedures on dilution of pneumococcal factor anti-sera on 29 October 2018 to prevent factor sera from becoming weaker over time. The manufacturer has contacted the affected customers via mail.
Product replacement is on-going.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 5 November 2018