Ventana Medical Systems Inc: ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.

Recall number

Z-2716-2011

Recalling firm

Ventana Medical Systems Inc

Product

ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.

Status

Terminated

Initiated

2011-05-16

Posted

2011-07-01

Terminated

2012-02-10

Reason

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.)

Root cause

Pending

Action

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) .

Quantity

3990 units (2981 in US)

Distribution

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

Lot, serial or model codes

Lot number: A05885 & B00988

510(k) numbers

["K984567","K990618"]

PMA numbers

["P020055","P990081"]

Product code

MYA

Firm FEI

1000125183

Firm city

Oro Valley

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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