Recall Z-2229-2019— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2229-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-15

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2019-07-15, terminated 2021-08-12. It names one FDA 510(k) clearance: K963498. 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.. Reason: Negative Bias with Lot EA9227..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-15
Terminated: 2021-08-12
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K963498 — FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.·cleared 1997-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.