Reported Aug 14, 2019 · Terminated

Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended…

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. · 500 Gbc Dr · Newark, DE · 19702-2466

Is this the product you have?

  • Dimension¿ Ferritin (FERR) Flex¿
  • reagent cartridge DM FERR Product UsageThe FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia
Lot codes and dates
    • Catalog Number RF440
    • SMN# 10444946 Lot #
  • EA9227 UDI00842768013867EA922719081510444946840
Amount recalled
815 kits

Where it was sold

Why it was recalled

Negative Bias with Lot EA9227.

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 Aug 12, 2021 · Data as of Sep 19, 4:50 PM UTC

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