Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-2229-2019

Z-2229-2019 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Newark, DE

FDA device recall Z-2229-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on July 15, 2019 and is designated Class II. Reason for recall: Negative Bias with Lot EA9227. The recall status is terminated (terminated August 12, 2021). Affected quantity: 815 kits.

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
July 15, 2019
Termination Date
August 12, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
815 kits

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.

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

Code Information

Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840

Other recalls by Siemens Healthcare Diagnostics, Inc.

  • Z-2890-2026 Class II — Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic (July 6, 2026)
  • Z-2880-2026 Class III — Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catal (June 26, 2026)
  • Z-2881-2026 Class III — Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 (June 26, 2026)
  • Z-2703-2026 Class II — Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. (June 8, 2026)
  • Z-2398-2026 Class II — Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007 (May 7, 2026)
  • Z-2005-2026 Class II — epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma (April 2, 2026)
  • Z-1980-2026 Class II — Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. (March 18, 2026)
  • Z-1657-2026 Class II — Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11 (February 23, 2026)
  • Z-1484-2026 Class II — Atellica CH Urine Albumin (UAlb). Material Number: 11537225 (January 20, 2026)
  • Z-0492-2026 Class II — 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adj (October 6, 2025)

FDA data resources