ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection kit is intended for in vitro di

FDA device recall Z-2716-2011 · posted 2011-07-01 · Terminated

Recall details

Recalling firm

Ventana Medical Systems Inc

Reason for recall

The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885 and lot B00988) and one lot of iView DAB Detection Kit (part number 760-091, lot B01057A.)

Action taken

The firm, Ventana, sent two letters dated May 16, 2011, an "URGENT Medical Device Recall" notice to customers who received the affected lots and an "URGENT Medical Device Correction" to customers of unaffected lots. The letters described the product, problem and actions to be taken. The customers were instructed to discontinue use of any kits from the lots identified above; follow their internal standard operating procedures for assessing potential impact to reported patient results, If their laboratory had already used kits from these lots; conduct visual inspections of any DAB chromogen dispensers in use as part of their daily maintenance routine; inspect their current inventory and contact their local customer support team (800-227-2155) to replace any unused or partially used kits from the affected lots. Ventana highly recommends use of same-slide controls, especially when testing for targets of therapy, to mitigate any impact on patient results. If you find a dispenser containing precipitate in lots not identified in this letter or have any questions and concerns, please notify/contact your local customer support team (800-227-2155) .

Root cause

Pending

Status

Terminated

Product code

MYA

Quantity affected

3990 units (2981 in US)

Distribution

Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.

Date initiated

2011-05-16

Date posted

2011-07-01

Date terminated

2012-02-10

Location

Oro Valley, AZ

Related 510(k) clearances