ultraView SISH Detection Kit recall
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
Why was ultraView SISH Detection Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 04015630972296, Lot Number: Y15133
- Product
- ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
- Recalling firm
- Ventana Medical Systems Inc
- Quantity
- 6 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,
- Recall date
- March 7, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)