Recall Z-0894-2022— Ventana Medical Systems Inc

Name: FDA recall Z-0894-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-20

Class II · Ongoing

Class II FDA medical device recall by Ventana Medical Systems Inc, initiated 2022-01-20. FDA's recall record names no specific 510(k) clearance for this event. Product: BenchMark ULTRA and DISCOVERY ULTRA Instruments. Reason: Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire..

Recalling firm: Ventana Medical Systems Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-01-20
Firm location: Oro Valley, AZ, United States

Product description

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Reason for recall

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

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