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 11067000
    • Software V1.20.0 and Lower
    • UDI 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 6, 2022 · Data as of Sep 19, 6:17 PM UTC

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