Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The 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.
Reported: August 14, 2019 Initiated: July 15, 2019 #Z-2229-2019
Product Description
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The 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.
Reason for Recall
Negative Bias with Lot EA9227.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 815 kits
- Distribution
- Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS MT NC NE NH NJ NY OK OR PR SD TN TX VA VT WA WI
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The 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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 815 kits.
Why was this product recalled? ▼
Negative Bias with Lot EA9227.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2229-2019.
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