Reported Nov 13, 2024 · Ongoing
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
- Lot codes and dates
- UDI-DI00809708121860
- Lot Numbers08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60
- Amount recalled
- 1292 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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