Z-0046-04

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

Name: Z-0046-04 Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent
Creator: Beckman Coulter Inc
Published: 2003-08-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-08-26 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc began a recall of Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent on 2003-08-26. The reason FDA records is "Package insert contains inaccurate information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0046-04
Status: Terminated
Initiated: 2003-08-26
Posted: 2003-10-15
Terminated: 2004-04-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent
Product code: GKZ Counter, Differential Cell
Reason for recall: Package insert contains inaccurate information.
Root cause tag: labeling and UDI
FDA root cause: Other
Quantity in commerce: 233
Distribution: United States and Canada
Product codes and lots: Lot 758031F1, Part number 6607073

Product code GKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)