Reported Dec 4, 2019 · Terminated
Atellica CH 930 Analyzer
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 930 Analyzer
- Lot codes and dates
SMN 11067000Software V1.20.0 and LowerUDI 00630414002163
- Amount recalled
- 1432
Where it was sold
Why it was recalled
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
This product could cause temporary or reversible health problems — stop using it.
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