Z-2717-2011

iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro...

Name: Z-2717-2011 iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro...
Creator: Ventana Medical Systems Inc
Published: 2011-05-16
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2011-05-16 / Terminated

FDA source

Ventana Medical Systems Inc began a recall of iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana)... on 2011-05-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2717-2011
Status: Terminated
Initiated: 2011-05-16
Posted: 2011-07-01
Terminated: 2012-02-10
Recalling firm: Ventana Medical Systems Inc
Product: iView DAB Detection Kit, Part number: 760-091 (05266157001) 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.
Product code: MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
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.)
FDA 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 in commerce: 25 units
Distribution: Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.
Product codes and lots: Lot number: B01057A

Product code MYA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)