ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111.
FDA device recall Z-0560-03 · posted 2003-02-21 · Terminated
Recall details
- Recalling firm
- Ventana Medical Systems Inc
- Reason for recall
- Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 60
- Distribution
- Nationwide to pathology laboratories and hospitals.
- Date initiated
- 2002-10-07
- Date posted
- 2003-02-21
- Date terminated
- 2004-05-03
- Location
- Tucson, AZ
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