Recall Z-1249-2025 ยท GGT Assay, Erythropoietin
Beckman Coulter, Inc.
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 r
| Date | Feb 28, 2025 (initiated Feb 3, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| 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 | 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, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052223 | ACCESS EPO ASSAY Beckman Coulter, Inc., Oct 6, 2006 |