Z-0928-03

iVIEW DAB Detecion Kit. Catalog Number 760-091

Name: Z-0928-03 iVIEW DAB Detecion Kit. Catalog Number 760-091
Creator: Ventana Medical Systems Inc
Published: 2003-05-07
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2003-05-07 / Terminated

FDA source

Ventana Medical Systems Inc began a recall of iVIEW DAB Detecion Kit. Catalog Number 760-091 on 2003-05-07. The reason FDA records is "Kit does not stain tissues properly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0928-03
Status: Terminated
Initiated: 2003-05-07
Posted: 2003-06-17
Terminated: 2004-05-03
Recalling firm: Ventana Medical Systems Inc
Product: iVIEW DAB Detecion Kit. Catalog Number 760-091
Product code: KTO Reagent, Immunoassay, Igg
Reason for recall: Kit does not stain tissues properly.
FDA root cause: Other
Action: Recall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.
Quantity in commerce: 409 kits
Distribution: Nationwide.
Product codes and lots: Lot 400566

Product code KTO

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)