Date Initiated by Firm | October 26, 2006 |
Date Posted | February 07, 2007 |
Recall Status1 |
Terminated 3 on April 30, 2012 |
Recall Number | Z-0417-2007 |
Recall Event ID |
37065 |
510(K)Number | K012208 |
Product Classification |
in vitro diagnostic - Product Code DDC
|
Product | Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890 |
Code Information |
518729 (expires 10/31/06); 520617 (expires 12/31/06); 612764 (expires 12/31/06); 613481 (expires 3/31/07); 614541 (expires 5/31/07); 616787 (expires 8/31/07) |
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 | Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. |
FDA Determined Cause 2 | Other |
Action | A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days. |
Quantity in Commerce | 474 units |
Distribution | Nationwide and Canada |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DDC
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