Reported May 7, 2025 · Ongoing
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc…
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 Crea Test Card (25 pk) for the epoc Blood Analysis System
- Siemens Material Number (SMN)10736382; epoc
- Software Version & Sensor Configuration
epoc Host SW v3.41.2epoc NXS SW v4.14.9 & 4.14.11Sensor Configuration 45.n
- Lot codes and dates
- Siemens Material Number (SMN)10736382
- Udi-DI00809708072254
- Lot NumbersAll lot numbers with prefix (xx) 00 or 06; epoc Software
- Version and Senor Configuration
epoc Host SW V3.41.2epoc NXS SW v4.14.9 & 4.14.11Sensor Configuration 45.n
- Amount recalled
- 5,207 units
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
- Nationwide
Why it was recalled
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
This product could cause temporary or reversible health problems — stop using it.
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