Z-3008-2018Class I

VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC)...

Name: Z-3008-2018 VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC)...
Creator: Ventana Medical Systems Inc
Published: 2018-08-02
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2018-08-02 / Terminated

FDA source

Ventana Medical Systems Inc began a recall of VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use on 2018-08-02. FDA classified it as Class I and gives the reason as "Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3008-2018
Classification: Class I
Status: Terminated
Initiated: 2018-08-02
Posted: 2018-09-14
Terminated: 2021-11-22
Recalling firm: Ventana Medical Systems Inc
Product: VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Product code: PPM General Purpose Reagent
Reason for recall: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
FDA root cause: Under Investigation by firm
Action: The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
Quantity in commerce: 559 units
Distribution: worldwide
Product codes and lots: Lot Numbers: Y15105, Y22455, UDI: 4015630971930

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3008-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2996-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-2997-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-2998-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-2999-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3000-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3001-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3002-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3003-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3004-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3005-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3006-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3007-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3008-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3009-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3010-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3011-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3012-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3013-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3014-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3015-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3016-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)