FDA Medical Device Recalls (openFDA)
Ventana Medical Systems Inc: CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939
- Recall number
- Z-0115-04
- Recalling firm
- Ventana Medical Systems Inc
- Product
- CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939
- Status
- Terminated
- Initiated
- 2003-04-04
- Posted
- 2003-11-19
- Terminated
- 2004-03-30
- Reason
- Increased level of non-specific or background staining.
- 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
- 95
- Distribution
- Nationwide and to Japan, France and Puerto Rico.
- Lot, serial or model codes
- Lot Numbers; 23095A, 23340A, and 30116A.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NKF
- Firm FEI
- 1000125183
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28