Z-0115-04

CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939

Name: Z-0115-04 CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939
Creator: Ventana Medical Systems Inc
Published: 2003-04-04
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2003-04-04 / Terminated

FDA source

Ventana Medical Systems Inc began a recall of CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939 on 2003-04-04. The reason FDA records is "Increased level of non-specific or background staining". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0115-04
Status: Terminated
Initiated: 2003-04-04
Posted: 2003-11-19
Terminated: 2004-03-30
Recalling firm: Ventana Medical Systems Inc
Product: CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939
Product code: NKF Immunohistochemistry Antibody Assay, C-Kit
Reason for recall: Increased level of non-specific or background staining.
FDA root cause: Other
Action: Customers were sent notice via letter on 4/4/2003. Confirmation of delivery has been obtained for all customers. Product recovery is underway.
Quantity in commerce: 95
Distribution: Nationwide and to Japan, France and Puerto Rico.
Product codes and lots: Lot Numbers; 23095A, 23340A, and 30116A.

Product code NKF

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)