Siemens Healthcare Diagnostics Inc. is recalling 1,292 units of the epoc BGEM BUN Test Card (25 pk) used with the epoc Blood Analysis System. These test cards may provide incorrectly low sodium readings approximately two months before they expire. While one customer complaint has been reported regarding this issue, there have been no reports of patient injuries. All affected test card lots have already reached their expiration dates.
The recalled test cards can show sodium levels that are up to 10 units (mmol/L) lower than the patient's actual level. This inaccuracy could lead healthcare providers to make incorrect diagnosis or treatment decisions based on faulty diagnostic data.
Manufacturer initiated recall due to sodium bias issue.
Quantity: 1292 units. All affected lots expired before the issuance of the recall.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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