Device product
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.
Z-2229-2019
Product summary
- Event
- Event 83384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 815 kits
- Official record key
device-enforcement:Z-2229-2019
Official wording
Reason: Negative Bias with Lot EA9227.
Code information: Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840
Distribution pattern: 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
Derived failure modes
-
Unknown
Negative Bias with Lot EA9227.