ClearanceBrief
Recall Z-0046-04 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc

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

DateOct 15, 2003 (initiated Aug 26, 2003)
StatusTerminated
ReasonPackage insert contains inaccurate information.
Root causeOther
Quantity233
DistributionUnited States and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.