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Immunohistochemistry Assay, Antibody, Progesterone Receptor

FDA product code MXZ · Class 2 · Hematology

33
Registered devices
9
Adverse events
3
Recalls
13
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2018-08-02Ventana Medical Systems IncLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
2004-04-06Zymed Laboratories Inc.Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
2004-04-06Zymed Laboratories Inc.Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.