Access Immunoasay Systems Digoxin Reagent
FDA device recall Z-0576-05 · posted 2005-03-08 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Variability in results on Patient and QC results of 20-25%, high and low.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KXT
- Quantity affected
- 4352 domestically.
- Distribution
- Nationwide and Canada
- Date initiated
- 2005-02-23
- Date posted
- 2005-03-08
- Date terminated
- 2005-09-02
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS DIGOXIN ASSAY (K925802) | Bio-Rad Laboratories, Inc. | 1993-01-13 |