Z-0034-2013Class II

CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous...

Name: Z-0034-2013 CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous...
Creator: Beckman Coulter Inc.
Published: 2012-05-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-05-22 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+... on 2012-05-22. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0034-2013
Classification: Class II
Status: Terminated
Initiated: 2012-05-22
Posted: 2012-10-10
Terminated: 2012-10-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Product code: GKZ Counter, Differential Cell
Reason for recall: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beckman Coulter sent a Product Corrective Action (PCA) letter dated May 22, 2012, with attached PCA Response Form to all customers who purchased the tetraCXP Software, CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that the tetraCXP SYSTEM Guide and CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 & CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 product labeling will be revised to reflect the updated claims. Customers were instructed to complete and return the enclosed Response form within 10 days. Customers with questions were instructed to contact Beckman Coulter Customer Service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter representative. For questions regarding this recall call 714-961-4483.
Quantity in commerce: 33,259 units total (8,458 units in US)
Distribution: Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay
Product codes and lots: All tetraCHROME lots manufactured

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0034-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0033-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0034-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0035-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10

Product code GKZ

K030408Class IICyto-Stat Tetrachrome Cd45-Fit/cd4-Pe/cd3-Pc5 Monoclonal Antibody Reagent, Cyto-Stat Tetrachrom Cd45-Fitc/cd56-Pe/cd19-aBeckman Coulter, Inc. / cleared 2003-03-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)