Z-1249-2025Class II

Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by...

Name: Z-1249-2025 Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by...
Creator: Beckman Coulter, Inc.
Published: 2025-02-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-02-03 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red... on 2025-02-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1249-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-03
Posted: 2025-02-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: GGT Assay, Erythropoietin
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.
FDA root cause: Unknown/Undetermined by firm
Action: Firm began notifying customers February 6, 2025. Customers were instructed to discontinue using and discard all remaining reagent packs of the Access EPO reagent lot identified. Customers are advised to share this recall with their medical director and perform a retrospective review of patient test results generated with this lot and assess the need for retesting.
Quantity in commerce: 498 US; 1576 OUS
Distribution: 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
Product codes and lots: Catalog A16364 UDI-DI 15099590201838 Lot 439363

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1249-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1249-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-02-28

Product code GGT

K052223Class IIAccess Epo AssayBeckman Coulter, Inc. / cleared 2006-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)