Beckman Coulter Access Unconjugated Estriol Assay Systems Recalled for Interference
Beckman Coulter is recalling Access Unconjugated Estriol assay systems because alkaline phosphatase interference may cause falsely elevated results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling 21,455 units of the BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol (REF 33570). The recall is due to alkaline phosphatase (ALP) associated interference, which can cause falsely elevated Unconjugated Estriol (uE3) assay results.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific lot numbers involved in this recall are 921133, 921348, and 921742.
Healthcare facilities and laboratories should stop using these specific lots of the assay system. Users should contact Beckman Coulter for instructions on how to return the affected products and obtain replacements.
The recalled product
- Product
- BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 21,455
Distribution
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