FDA Medical Device Recalls (openFDA)
Ventana Medical Systems Inc: iVIEW DAB Detecion Kit. Catalog Number 760-091
- Recall number
- Z-0928-03
- Recalling firm
- Ventana Medical Systems Inc
- Product
- iVIEW DAB Detecion Kit. Catalog Number 760-091
- Status
- Terminated
- Initiated
- 2003-05-07
- Posted
- 2003-06-17
- Terminated
- 2004-05-03
- Reason
- Kit does not stain tissues properly.
- Root cause
- Other
- Action
- Recall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.
- Quantity
- 409 kits
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 400566
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KTO
- 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