Z-0560-03

ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111

Name: Z-0560-03 ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111
Creator: Ventana Medical Systems Inc
Published: 2002-10-07
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2002-10-07 / Terminated

FDA source

Ventana Medical Systems Inc began a recall of ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111 on 2002-10-07. The reason FDA records is "Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0560-03
Status: Terminated
Initiated: 2002-10-07
Posted: 2003-02-21
Terminated: 2004-05-03
Recalling firm: Ventana Medical Systems Inc
Product: ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.
Reason for recall: Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.
FDA 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 in commerce: 60
Distribution: Nationwide to pathology laboratories and hospitals.
Product codes and lots: Lot numbers: R20061A, R20429A, R21002A, and R21002B.

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)