Recall Z-2716-2011 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
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 sectio
| Date | Jul 1, 2011 (initiated May 16, 2011) |
| Status | Terminated |
| 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 disp |
| Quantity | 3990 units (2981 in US) |
| Distribution | Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel. |
| FDA record | Open on fda.gov |