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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Ferritin (FERR) Flex reagent cartridge

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  Class 2 Device Recall Dimension Ferritin (FERR) Flex reagent cartridge see related information
Date Initiated by Firm July 15, 2019
Create Date August 08, 2019
Recall Status1 Terminated 3 on August 12, 2021
Recall Number Z-2229-2019
Recall Event ID 83384
510(K)Number K963498  
Product Classification Radioimmunoassay (two-site solid phase), ferritin - Product Code JMG
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.
Code Information Catalog Number RF440, SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information Contact Edward Szymanski
302-631-7672
Manufacturer Reason
for Recall		 Negative Bias with Lot EA9227.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JMG and Original Applicant = DADE CHEMISTRY SYSTEMS, INC.
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