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U.S. Department of Health and Human Services

Class 1 Device Recall ultraView SISH DNP Detection Kit

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  Class 1 Device Recall ultraView SISH DNP Detection Kit see related information
Date Initiated by Firm December 19, 2017
Date Posted February 27, 2018
Recall Status1 Terminated 3 on November 22, 2021
Recall Number Z-0739-2018
Recall Event ID 78942
Product Classification General purpose reagent - Product Code PPM
Product ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
Code Information UDI 04015630972135, Lot Number: Y17990  
Recalling Firm/
Ventana Medical Systems Inc
1910 E Innovation Park Dr
Oro Valley AZ 85755-1962
For Additional Information Contact
Manufacturer Reason
for Recall
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
FDA Determined
Cause 2
Process control
Action On Dec 19th all Roche affiliates (the direct consignees) worldwide were notified via Safety Board Notification (SBN) and subsequent Field Safety Notification (EX-US) and UMDC TD00090 (US) SBN and FSN revised Dec 20th due to 3 affected part numbers missed on original letter. The instructions are as follows: "Actions taken by Roche Diagnostics All affected product has been placed on hold. Ventana has reworked all product in its inventory and is in the process of manufacturing new lots for distribution and replacement of customer affected kits. Customers will be notified when corrected product is available. Actions to be taken by the customer/user Affected kits may continue to be used by customers until corrected product is available, however Ventana is mandating that the affected IHC detection kits (iView, ultraView, OptiView) must only be used in conjunction with same-slide controls. These controls must be appropriate for each assay and capable of detecting false negative results due to a complete or partial reagent dispense failure. CINtec PLUS Cytology does not have the capacity for same slide controls, so system-level controls should be maintained. ultraView SISH Detection is used for HER2 analysis, and employs internal positive controls; no external control is required. For assays that directly relate to clinical therapy decision making (e.g. ER/PR, HER2, ALK, etc.), it is additionally important to select a same slide positive control tissue with sufficient sensitivity to detect small decreases in intensity that may cause borderline positive cases to appear as negative (e.g. HER2 2+ vs. 1+). Although the use of same slide controls is considered optimal laboratory practice and strongly recommended by Ventana, customers may revert to standard run controls once non-impacted product is received. In order to reduce the risk of this issue impacting patient care, customers not using same slide controls as a standard practice should follow their
Quantity in Commerce 358 units
Distribution Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.