| Date Initiated by Firm | January 27, 2003 |
|---|
| Date Posted | March 06, 2003 |
|---|
| Recall Status1 |
Terminated 3 on October 08, 2003 |
| Recall Number | Z-0619-03 |
|---|
| Recall Event ID |
25482 |
| 510(K)Number | K922823 |
|---|
| Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
|
| Product | Access and Access 2 Immunoassay Systems
862.2160 Discrete photometric chemistry analyzer for clinical use. |
|---|
| Code Information |
Not applicable. |
| FEI Number |
2050012
|
Recalling Firm/
Manufacturer |
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
|
| For Additional Information Contact | Lynne McBride
714-961-3626 |
|---|
Manufacturer Reason
for Recall | Spring failure, design defect in component. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment) |
|---|
| Quantity in Commerce | 2418 |
|---|
| Distribution | Product has been distributed in US from 8/92 to present. All these units are affected. |
|---|
| 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 = JJE
|
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