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Terminated

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

FDA Recall Z-0560-03 · Posted 2003-02-21

Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Date Initiated2002-10-07
Date Terminated2004-05-03
Product Quantity60

Reason for Recall

Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide to pathology laboratories and hospitals.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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