Recalls / —

—#29678

Product

Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent

FDA product code

GKZ — Counter, Differential Cell

Device class

Class 2

Medical specialty

Hematology

Affected lot / code info

Lot 758031F1, Part number 6607073

Why it was recalled

Package insert contains inaccurate information.

Root cause (FDA determination)

Other

Recalling firm

Firm

Beckman Coulter Inc

Address

200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern

United States and Canada

Timeline

Recall initiated

2003-08-26

Posted by FDA

2003-10-15

Terminated

2004-04-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.