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uE3 AccuBind ELISA Test System - 192 Wells
MONOBIND, INC. · Model 5025-300 · UDI-DI 00816870021409
CGI
Prescription
10
510(k) clearances
16
Adverse events
2
Recalls
18
Facilities
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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