FDA Device recall Z-0732-2018
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
- FDA Device
- Class I
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class I recall of ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 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-0732-2018 |
| 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
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 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 04015630972296, Lot Number: Y15133 |
|---|
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-0732-2018%22
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