Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Reported: March 7, 2018 Initiated: December 19, 2017 #Z-0738-2018
Product Description
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
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.
Details
- Recalling Firm
- Ventana Medical Systems Inc
- Units Affected
- 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,
- Location
- Oro Valley, AZ
Frequently Asked Questions
What product was recalled? ▼
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic. Recalled by Ventana Medical Systems Inc. Units affected: 71640 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Critical. Recall number: Z-0738-2018.
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