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Terminated

INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Recall Z-3014-2018 · Posted 2018-09-14

Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeMAQ
Date Initiated2018-08-02
Date Terminated2021-11-22
Product Quantity195 units

Reason for Recall

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

Firm Action

The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.

Root Cause

Under Investigation by firm

Distribution Pattern

worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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