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Terminated

VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.

FDA Recall Z-3010-2018 · Posted 2018-09-14

Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeOWF
Date Initiated2018-08-02
Date Terminated2021-11-22
Product Quantity2753 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101234VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYVentana Medical Systems, Inc. · 2011-08-25

Official Source

View FDA Recall →

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

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