Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2229-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 15, 2019

Date Posted: August 14, 2019

Recall Number: Z-2229-2019

Event ID: 83384

Reason for Recall:

Negative Bias with Lot EA9227.

Status: Terminated

Product Quantity: 815 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated