CLASS I Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Hematoxylin II, Ventana recalled by Ventana Medical Systems
Ventana Medical Systems is recalling Hematoxylin II, Ventana, distributed nationwide in the US. The recall was initiated on 19 Dec 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0738-2018
- FDA event ID
- 78942
- Recalling firm
- Ventana Medical Systems, Oro Valley, AZ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Dec 2017
- FDA classified
- 14 Sep 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Dec 2017 | Recall initiated by company | |
| 7 Mar 2018 | Published in enforcement report | +78 days |
| 14 Sep 2018 | Classified by FDA | +191 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Where it was distributed
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,
Questions about this recall
Is Hematoxylin II, Ventana recalled?
Yes. Ventana Medical Systems recalled Hematoxylin II, Ventana on 19 Dec 2017. The recall is Class I and its status is Terminated. Recall number Z-0738-2018.
Why was it recalled?
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.
Which lots are affected?
UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561
Where was it sold?
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,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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