VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Onl

FDA device recall Z-0833-2013 · posted 2013-08-06 · Terminated

Recall details

Recalling firm

Ventana Medical Systems Inc

Reason for recall

Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and u

Action taken

The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.

Root cause

Device Design

Status

Terminated

Product code

KPA

Quantity affected

1735 instruments

Distribution

Worldwide distribution: USA (nationwide) and country of: Germany.

Date initiated

2012-09-28

Date posted

2013-08-06

Date terminated

2016-02-24

Location

Oro Valley, AZ