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EPO (Erythropoietin) ELISA
DRG International Inc · Model EIA-3646 · UDI-DI 00840239036469
GGT
Prescription
10
510(k) clearances
3
Adverse events
5
Recalls
9
Facilities
Description
The EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.