Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Epocal Inc. (Siemens) epoc BGEM BUN Test Card [HKMD No.: 210419].
According to FDA, the manufacturer has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95504
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 Nov 2024