Reported Sep 17, 2025 · Ongoing
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
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. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
- Material Number11097543
- Lot codes and dates
- Material Number11097543
- Test CodeUCFP
- UDI-DI00630414279206. All lot numbers
- Amount recalled
- 11,811 units
Where it was sold
- Nationwide
- GA
Why it was recalled
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
This product could cause temporary or reversible health problems — stop using it.
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