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EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]
BIOMERICA, INC. · Model 7025 · UDI-DI 08305900070255
1
510(k) clearances
3
Adverse events
5
Recalls
9
Facilities
Description
The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-03 | Beckman Coulter, Inc. | Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demons |
| 2024-01-24 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that i |
| 2024-01-24 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that i |
| 2022-06-14 | R & D Systems, Inc. | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the |
| 2005-09-30 | Nichols Institute Diagnostics | Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Ve |
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