Medical Device Recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Siemens Healthcare Diagnostics Inc · September 24, 2024
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.
Distribution
US Nationwide. Canada.
States Affected
NATIONWIDE
Quantity Affected
1292 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0286-2025
Status: ongoing
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