Home › Ventana Medical Systems, Inc. › VENTANA antiHelicobacter pylori SP48 Rabbit Monoclonal Primary Antibody
VENTANA antiHelicobacter pylori SP48 Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. · Model 250 tests · UDI-DI 04015630970018
OWF
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
3
Facilities
Description
250 Test
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. |
| 2017-05-05 | Cell Marque Corporation | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as requir |
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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.