Device Recall iView DAB Detection Kit 의 리콜

Recall

58855

Class 2

Z-2717-2011

2011-05-16

2011-07-01

Terminated

United States

2012-02-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100423

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.).

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) .