Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal fa…
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 af…
Open FDA's page for this record- Cfres ID
- 212434
- Product res number
- Z-1249-2025
- Event date initiated
- 2025-02-03
- Event date posted
- 2025-02-28
- Recall status
- Open, Classified
- Res event number
- 96255
- Product code
- GGT
- Code info
- Catalog A16364 UDI-DI 15099590201838 Lot 439363
- Firm FEI number
- 2122870
- Recalling firm
- Beckman Coulter, Inc.
- Address 1
- 1000 Lake Hazeltine Dr
- City
- Chaska
- State
- MN
- Postal code
- 55318-1037
- Additional info contact
- Ian Pilcher 952-448-4848
- Root cause description
- Unknown/Undetermined by firm
- 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.
- 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.
- 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
- K numbers
- K052223
- Harmonized identifiers (openFDA)
- Device name
- Assay, Erythropoietin
- Medical specialty description
- Hematology
- Regulation number
- 864.7250
- Device class
- 2
- K number
- K936016, K894943, K983203, K980737, K926390, K932650, K833957, K052223, K931666, K882686, K910481, K931756, K952559, K893393, K902639, K183088, K954898, K240182, K903492, K992799
- Registration number
- 1222302, 3002800697, 8032314, 2432235, 2182501, 3002806944, 2025099, 2245285, 2122870
- FEI number
- 3002808140, 3007981058, 3002800697, 1000121039, 2432235, 2182501, 3002806944, 2245285, 2122870