Recall Z-2229-2019 ยท JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
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.
| Date | Jul 15, 2019 |
| Status | Terminated |
| Reason | Negative Bias with Lot EA9227. |
| 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 associate |
| Quantity | 815 kits |
| Distribution | Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963498 | FERR FLEX REAGENT CARTRIDGE Dade Chemistry Systems, Inc., Jan 24, 1997 |