Recall Z-0035-2013 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
TetraCXP Software System, Part Number A40051. 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 perc
| Date | Oct 10, 2012 (initiated May 22, 2012) |
| Status | Terminated |
| Reason | 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 | 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 t |
| Quantity | 146 units total (37 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 Poly |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030828 | TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) Beckman Coulter, Inc., May 21, 2003 |