| Date Initiated by Firm | July 18, 2005 |
|---|
| Date Posted | August 23, 2005 |
|---|
| Recall Status1 |
Terminated 3 on March 07, 2012 |
| Recall Number | Z-1388-05 |
|---|
| Recall Event ID |
32748 |
| 510(K)Number | K981354 |
|---|
| Product Classification |
Kit, Test,Alpha-Fetoprotein For Testicular Cancer - Product Code LOJ
|
| Product | Access Immunoassay Systems Assay Protocol: Dil-AFP. |
|---|
| Code Information |
All lot numbers. |
Recalling Firm/
Manufacturer |
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
|
| For Additional Information Contact | Nancy E. Johnson
714-961-4489 |
|---|
Manufacturer Reason
for Recall | Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Letters to customers were sent July 18, 2005. Firm will upgrade software later in the year. Customers are advised to not perform the automated dilution protocol but refer to the method in the directions. |
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| Quantity in Commerce | 311 USA 16 Canada |
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| Distribution | Nationwide and Canada |
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| 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 = LOJ
|
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