Access Immunoasay Systems Digoxin Reagent
This recall has been terminated (originally issued March 8, 2005).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- February 23, 2005
- Posted
- March 8, 2005
- Terminated
- September 2, 2005
- Recall Number
- Z-0576-05
- Quantity
- 4352 domestically.
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Variability in results on Patient and QC results of 20-25%, high and low.
Distribution
Nationwide and Canada
Lot / Code Info
Lots 323171; 416110; 417703; 419534
Root Cause
Other
Action Taken
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.
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