FDA Medical Device Recalls (openFDA)
Ventana Medical Systems Inc: ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.
- Recall number
- Z-0560-03
- Recalling firm
- Ventana Medical Systems Inc
- Product
- ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.
- Status
- Terminated
- Initiated
- 2002-10-07
- Posted
- 2003-02-21
- Terminated
- 2004-05-03
- Reason
- Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.
- Root cause
- Other
- Action
- Customers were notified by letter sent on 9/27/2002. Product has been replaced and this recall is complete. No injuries or illness was reported.
- Quantity
- 60
- Distribution
- Nationwide to pathology laboratories and hospitals.
- Lot, serial or model codes
- Lot numbers: R20061A, R20429A, R21002A, and R21002B.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- 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