Medical device manufacturer, Roche, has issued a medical device safety alert concerning its Tina-quant Soluble Transferrin Receptor (sTFR) assay. The affected products are identified as follow:
During the feasibility study for the new affected product generation, it was observed that the current claim for rheumatoid factors (RF) interference cannot be confirmed for the current STFR assay. Currently, the claim for this assay is that there is no significant interference of RF up to a concentration of 750 IU/mL for cobas c systems and 500 IU/mL for COBAS INTEGRA 400 plus analyzer.
According to the manufacturer, the most recent internal investigations have confirmed that there is no significant interference of rheumatoid factors up to a concentration of 150 IU/mL for cobas c systems and 120 IU/mL for COBAS INTEGRA 400 plus analyzer. As the RF value is not known by the customer in most cases, the detectability of the interference is difficult. However, implausible results should be noted, since STFR should never be used alone for diagnosis, but always interpreted in combination with other parameters (e.g. Ferritin, Transferrin, Iron).
Due to the residual medical risk associated with the issue, customers using the affected product must follow the actions as described below.
The manufacturer will update the claims in the respective method sheets:
Customers are advised to take into consideration the new RF interference limits as mentioned.
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 21 August 2019