Reported Aug 17, 2016 · Terminated
Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body…
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?
- Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP
- SMN
1044483410453531
- Lot codes and dates
- All software versions and serial numbers
- Amount recalled
- 977 units
Why it was recalled
Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
This product could cause temporary or reversible health problems — stop using it.
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