Recall Z-0286-2025— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-0286-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-24

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2024-09-24. It names one FDA 510(k) clearance: K200107. Product: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515. Reason: Siemens Healthcare Diagnostics Inc. 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. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-09-24
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 (25 pk) for the epoc Blood Analysis System, SMN 10736515

Reason for recall

Siemens Healthcare Diagnostics Inc. 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. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.

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