Beckman Coulter Inc Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lot 758031F1, Part number 6607073
Products Sold
Lot 758031F1, Part number 6607073
Beckman Coulter Inc is recalling Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent due to Package insert contains inaccurate information.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
Package insert contains inaccurate information.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026