Z-2229-2019Class II

Dimension Ferritin (FERR) Flex reagent cartridge DM FERR

Name: Z-2229-2019 Dimension Ferritin (FERR) Flex reagent cartridge DM FERR
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-07-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-07-15 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2019-07-15. FDA classified it as Class II and gives the reason as "Negative Bias with Lot EA9227". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2229-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-15
Posted: 2019-08-08
Terminated: 2021-08-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Reason for recall: Negative Bias with Lot EA9227.
FDA root cause: Under Investigation by firm
Action: Siemens sent an Urgent Field Safety Notice letter dated July 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Review the letter with their Medical Director 2. Discontinue use and discard the kit. 3. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. send a scanned copy of the completed form via email to or fax this completed form to the Customer Care Center at 312-275-7795. 4. If you have received any complaints of illness or adverse events associated with the product listed in the letter, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative. 5. Retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 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
Product codes and lots: Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2229-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2229-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-08

Product code JMG

K963498Class IIFerr Flex Reagent CartridgeDade Chemistry Systems, Inc. / cleared 1997-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)