FDA Device recall Z-0735-2018
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
- FDA Device
- Class I
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class I recall of CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic by Ventana Medical Systems, citing 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 CINt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0735-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-12-19 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ventana Medical Systems |
| Distribution | US |
Product
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Reason
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.
Identifiers
| code_info | UDI 04015630976287, Lot Numbers: Y22162, Y15546 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0735-2018%22
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