Reported Sep 6, 2023 · Ongoing
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
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 with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Lot codes and dates
- UDI-DI00809708121860
- Siemens Material Number10736515
- Lots
04-23003-60 (expiry 20-Jun-2023)11-22337-60 (expiry 20-May-2023)04-23034-40 (expiry 21-Jul-2023)04-23059-50 (expiry 15-Aug-2023)04-23059-60 (expiry 15-Aug-2023)and 04-23069-40 (expiry 25-Aug-2023)
- Amount recalled
- 3201 ea
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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