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Anti-ER (Insite)

BIOGENEX LABORATORIES · Model MU368-5UC · UDI-DI 00850646007112

MYA
1
510(k) clearances
19
Adverse events
3
Recalls
10
Facilities

Recalls

DateFirmReason
2018-08-02Ventana Medical Systems IncLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
2011-05-16Ventana Medical Systems IncThe recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Unive
2011-05-16Ventana Medical Systems IncThe recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Unive

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.