Dimension¿ Ferritin — Class II medical device recall Z-2229-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-08-14, distributed in AK, AR, AZ, CA, CT, FL, GA, IA…. Negative Bias with Lot EA9227.
| Recall number | Z-2229-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2019-07-15 |
| Classified | 2019-08-08 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2021-08-12 |
| Distributed | 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 |
| Quantity | 815 kits |
| UPC / GTIN / UDI-DI | 00842768013867 |
| Lot numbers | EA9227 |
| Model numbers | 10444946, RF440 |
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.
Reason for recall
Negative Bias with Lot EA9227.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2229-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.