Recall Z-3010-2018— Ventana Medical Systems Inc

Name: FDA recall Z-3010-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-02

Class I · Terminated

Class I FDA medical device recall by Ventana Medical Systems Inc, initiated 2018-08-02, terminated 2021-11-22. It names one FDA 510(k) clearance: K101234. Product: VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.. Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur..

Recalling firm: Ventana Medical Systems Inc
Classification: Class I
Status: Terminated
Initiated: 2018-08-02
Terminated: 2021-11-22
Firm location: Oro Valley, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K101234 — VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYVentana Medical Systems, Inc.·cleared 2011-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.