Siemens Healthcare Diagnostics, Inc. 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Negative Bias with Lot EA9227.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OK, OR, SD, TN, TX, VT, VA, WA, WI, PR