Recall Z-0576-05 ยท KXT Enzyme Immunoassay, Digoxin
Beckman Coulter Inc
Access Immunoasay Systems Digoxin Reagent
| Date | Mar 8, 2005 (initiated Feb 23, 2005) |
| Status | Terminated |
| Reason | Variability in results on Patient and QC results of 20-25%, high and low. |
| Root cause | Other |
| Action | 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. |
| Quantity | 4352 domestically. |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925802 | ACCESS DIGOXIN ASSAY Bio-Rad Laboratories, Inc., Jan 13, 1993 |