Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Recommended Action

Per FDA guidance

An Urgent Medical Device Correction notification letter dated 01/24/24 was sent to customers. Actions to be Taken by the Customer: Discontinue use of and discard the EPO kit lots listed in Table 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. For continued EPO patient testing in your laboratory during this time, please contact your Siemens representative to discuss alternative Siemens Healthineers solutions. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.