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Progesterone Receptor (PR) [PgR636]
BIOCARE MEDICAL LLC · Model APA343AA · UDI-DI 00847627002020
MXZ
Prescription
10
510(k) clearances
9
Adverse events
3
Recalls
13
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-02 | Ventana Medical Systems Inc | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
| 2004-04-06 | Zymed Laboratories Inc. | Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings. |
| 2004-04-06 | Zymed 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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Get your free API keyRead the docsData 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.
