—#49841

Product

Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890

FDA product code: DDC — Thyroglobulin, Antigen, Antiserum, Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K012208
Affected lot / code info: 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)

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2006-10-26
Posted by FDA: 2007-02-07
Terminated: 2012-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.