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Access EPO
Beckman Coulter, Inc. · Model A16364 · UDI-DI 15099590201838
GGT
Prescription
10
510(k) clearances
3
Adverse events
5
Recalls
9
Facilities
Description
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended 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 of 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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