CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 — Class II medical device recall Z-0033-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-17, distributed nationwide. The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stabilit
| Recall number | Z-0033-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-05-22 |
| Classified | 2012-10-10 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2012-10-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BB, BD, BE, BG, BH, CA, CH, CL, CN, CO, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LT, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PK, PL, QA, RO, SA, SE, SG, SI, SK, SV, TR, TW, UY, ZA |
| Reason classes | labeling, specification failure, software |
| Model numbers | 6607013 |
Product
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. 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.
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.