Agency classClass IOur severity:Severe FDA (Devices)·Z-0735-2018·Announced 2018-03-07

Ventana Recalls CINtec PLUS Cytology Kits Due to Leaking Reagent Dispensers

Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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 Hematoxylin II."

Plain-English summary

Ventana Medical Systems Inc is recalling 18 units of the CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, and Roche GMMI 06889549001 in vitro diagnostic. The affected units are identified by UDI 04015630976287 and Lot Numbers Y22162 and Y15546.

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 components 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 kits should stop using the affected dispensers and contact the manufacturer for further instructions.

The recalled product

Product: CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Manufacturer: Ventana Medical Systems Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: mechanical-defect
leaking
Affected units: 18

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 04015630976287
Lot Numbers: Y22162
Y15546

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.

See all 12 products in this recall →

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