Z-0738-2018Class I

Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

Name: Z-0738-2018 Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Creator: Ventana Medical Systems Inc
Published: 2017-12-19
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2017-12-19 / Terminated / root cause: manufacturing process

FDA source

Ventana Medical Systems Inc began a recall of Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic on 2017-12-19. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0738-2018
Classification: Class I
Status: Terminated
Initiated: 2017-12-19
Posted: 2018-02-27
Terminated: 2021-11-22
Recalling firm: Ventana Medical Systems Inc
Product: Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Product code: HYJ Hematoxylin
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 71640 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,
Product codes and lots: UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0738-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0729-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0730-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0731-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0732-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0733-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0734-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0735-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0736-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0737-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0738-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0739-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14
Z-0740-2018	Class I	Terminated	Voluntary: Firm initiated	2018-03-07	2018-09-14

Product code HYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)