| Date Initiated by Firm | December 15, 2005 |
|---|
| Date Posted | February 04, 2006 |
|---|
| Recall Status1 |
Terminated 3 on January 26, 2012 |
| Recall Number | Z-0474-06 |
|---|
| Recall Event ID |
34380 |
| 510(K)Number | K011342 |
|---|
| Product Classification |
Counter, Differential Cell - Product Code GKZ
|
| Product | COULTER LH 700 Series Hematology Analyzer, PN
6605632 and 6605632R |
|---|
| Code Information |
PN 6605632 and 6605632R All Software Versions |
Recalling Firm/
Manufacturer |
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
|
| For Additional Information Contact | Nora Zerounian
714-961-3634 |
|---|
Manufacturer Reason
for Recall | There is a risk of sample misidentification when processing samples in the Manual aspiration mode. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail) |
|---|
| Quantity in Commerce | 1715 |
|---|
| 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 = GKZ
|
|---|
