FDA Recall
Terminated
ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.
Recall: Z-0560-03
·
Initiated October 7, 2002
Recall
- Recall Number
- Z-0560-03
- Event Number
- 25425
- Firm
- Ventana Medical Systems Inc
- FEI Number
- 1000125183
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 7, 2002
- Posted
- February 21, 2003
- Terminated
- May 3, 2004
- Address
- 1910 E Innovation Park Dr, Tucson, AZ, 85737
Description
ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.
Reason
Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.
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.
Distribution
Nationwide to pathology laboratories and hospitals.
Quantity
60