Ventana Recalls CINtec PLUS Cytology Kit Due to Leaking Reagent Dispensers
Ventana Medical Systems is recalling 748 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Ventana Medical Systems Inc is recalling 748 units of the CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001. The affected lot numbers are Y14122 and Y18107, with UDI 04015630972807. The recall is classified as Class I by the U.S. Food and Drug Administration.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers and with Hematoxylin II. These dispensers are part of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit.
The affected products were distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. Users of these in vitro diagnostic kits should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 748
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI 04015630972807
- Lot Numbers: Y14122
- Y18107
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Ventana Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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