Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. P

FDA device recall Z-2118-2013 · posted 2013-08-28 · Terminated

Recall details

Recalling firm

Ventana Medical Systems Inc

Reason for recall

Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.

Action taken

Ventana sent an Urgent Medical Device Correction Notification letter dated June 16, 2008 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to carefully read and perform all of the actions outlined in the notification letter concerning potential safety issue. Customers with concerns regarding the staining results on any patient specimen are instructed to follow their internal Quality Procedures regarding the review of patient reports. For question contact your local Customer Service Center.

Root cause

Device Design

Status

Terminated

Product code

KPA

Quantity affected

1217 units total

Distribution

Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.

Date initiated

2008-06-12

Date posted

2013-08-28

Date terminated

2013-08-29

Location

Tucson, AZ