Radioimmunoassay, Estriol
Beckman Coulter, Inc.'s record for this product code
MDR events1All time
Recalls2All time
510(k) clearances0All time
Recent MDR events
1 adverse event reports on file
Recalls
2 recall events for this product code
- TerminatedAug 15, 2011
The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release.
View FDA record ↗ - TerminatedUnknown
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Beckman Coulter, Inc. under this product code.