Z-0417-2007

Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890

Name: Z-0417-2007 Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
Creator: Beckman Coulter Inc
Published: 2006-10-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-10-26 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890 on 2006-10-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0417-2007
Status: Terminated
Initiated: 2006-10-26
Posted: 2007-02-07
Terminated: 2012-04-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
Product code: DDC Thyroglobulin, Antigen, Antiserum, Control
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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)

Product code DDC

K012208Class IIAccess Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models 33890, 33895Beckman Coulter, Inc. / cleared 2001-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)