Recall Z-2272-2025— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2272-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-07

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2025-07-07. It names one FDA 510(k) clearance: K200107. Product: epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.. Reason: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 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..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-07-07
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K200107 — epoc Blood Analysis SystemEpocal, Inc.·cleared 2020-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

Reason for recall

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.