Ventana Medical Systems Inc: ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

Recall number

Z-0739-2018

Recalling firm

Ventana Medical Systems Inc

Product

ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

Status

Terminated

Initiated

2017-12-19

Posted

2018-02-27

Terminated

2021-11-22

Reason

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.

Root cause

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

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,

Lot, serial or model codes

UDI 04015630972135, Lot Number: Y17990

510(k) numbers

not on file

PMA numbers

not on file

Product code

PPM

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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