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Free Estriol
DRG International Inc · Model HYE-5351 · UDI-DI 00840239053510
CGI
Prescription
10
510(k) clearances
16
Adverse events
2
Recalls
18
Facilities
Description
The DRG:HYBRId-XL Free Estriol is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol in serum.
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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