Beckman Coulter Inc Access Immunoasay Systems Digoxin Reagent Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Access Immunoasay Systems Digoxin Reagent
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lots 323171, 416110, 417703, 419534
Products Sold
Lots 323171; 416110; 417703; 419534
Beckman Coulter Inc is recalling Access Immunoasay Systems Digoxin Reagent due to Variability in results on Patient and QC results of 20-25%, high and low.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Variability in results on Patient and QC results of 20-25%, high and low.
Recommended Action
Per FDA guidance
Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.
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