Home / Recalls / Beckman Coulter, Inc. / Z-1249-2025

Z-1249-2025 Class II Ongoing

Recalled by Beckman Coulter, Inc. — Chaska, MN

FDA device recall Z-1249-2025 was initiated by Beckman Coulter, Inc. on February 3, 2025 and is designated Class II. Reason for recall: 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 fal… The recall status is ongoing. Affected quantity: 498 US; 1576 OUS.

Recall Details

Product Type
Devices
Report Date
March 12, 2025
Initiation Date
February 3, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
498 US; 1576 OUS

Product Description

Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.

Reason for Recall

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.

Distribution Pattern

Domestic distribution to AL AR AZ CA CT FL ID IL IN KS MA MI NC NE NJ NY OH OR PA TN TX UT WA WV. International distribution to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Russian Federation, Saudi Arabia, Slovakia, Spain, United Kingdom of Great Britain and Northern Ireland

Code Information

Catalog A16364 UDI-DI 15099590201838 Lot 439363

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  • Z-0889-2026 Class II — Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process (November 7, 2025)
  • Z-0429-2026 Class II — Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemi (October 1, 2025)
  • Z-0428-2026 Class II — Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemi (October 1, 2025)

FDA data resources