| Date Initiated by Firm | February 23, 2005 |
|---|
| Date Posted | March 08, 2005 |
|---|
| Recall Status1 |
Terminated 3 on September 02, 2005 |
| Recall Number | Z-0576-05 |
|---|
| Recall Event ID |
31253 |
| 510(K)Number | K925802 |
|---|
| Product Classification |
Enzyme Immunoassay, Digoxin - Product Code KXT
|
| Product | Access Immunoasay Systems Digoxin Reagent |
|---|
| Code Information |
Lots 323171; 416110; 417703; 419534 |
Recalling Firm/
Manufacturer |
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
|
| For Additional Information Contact | Kathleen Jaker
714-961-4123 |
|---|
Manufacturer Reason
for Recall | Variability in results on Patient and QC results of 20-25%, high and low. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 4352 domestically. |
|---|
| Distribution | Nationwide and Canada |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = KXT
|
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