Access Erythropoietin Reagent Lot Produces Falsely Decreased Test Results
Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for inaccurate laboratory test results with no reported illnesses or injuries. The defect poses a risk of misdiagnosis and unnecessary repeat testing, meeting the rubric criterion for High severity.
Plain-English summary
Beckman Coulter, Inc. is recalling lot 439363 of the Access Erythropoietin (EPO) reagent (catalog number A16364). This is a laboratory test used to measure erythropoietin levels in patient blood samples. Erythropoietin is a hormone produced primarily by the kidneys that regulates the production of red blood cells.
Testing of lot 439363 revealed a negative dose drop of -22% compared to alternate reagent lots when tested with native patient samples. This defect causes the reagent to produce results that are consistently lower than they should be.
Patient samples tested with lot 439363 may show falsely decreased EPO results. These inaccurate test results may lead to improper clinical diagnosis or the need for repeat testing. The affected lot was distributed to 498 facilities in the United States and 1,576 facilities internationally.
The recalled product
- 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…
- Manufacturer
- Beckman Coulter, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog A16364 UDI-DI 15099590201838 Lot 439363
Distribution
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