CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enu
FDA device recall Z-0033-2013 · posted 2012-10-10 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 137,445 units total (26,155 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
- Date initiated
- 2012-05-22
- Date posted
- 2012-10-10
- Date terminated
- 2012-10-10
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A (K030408) | Beckman Coulter, Inc. | 2003-03-04 |