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Free Estriol ELISA
DRG International Inc · Model EIA-1612 · UDI-DI 00840239016126
CGI
Prescription
10
510(k) clearances
16
Adverse events
2
Recalls
18
Facilities
Description
The DRG Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-26 | Beckman Coulter Inc. | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. |
| 2009-12-08 | Beckman Coulter Inc. | 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 |
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