Official recall record
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal fa
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-02-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590201838
- Brand on record
- Beckman Coulter, Inc.
- Product category
- Medical Device
What the authority reported
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 demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-03-16 · US FDA — Medical Devices
Access Total T4 Calibrator, Catalog No. 33805 - 2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit - 2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin S
All 32 official recall notices naming Beckman Coulter, Inc. on this site →
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