Z-2355-2010

Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin...

Name: Z-2355-2010 Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin...
Creator: Beckman Coulter Inc.
Published: 2010-06-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-06-29 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the... on 2010-06-29. The reason FDA records is "The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2355-2010
Status: Terminated
Initiated: 2010-06-29
Posted: 2010-09-02
Terminated: 2012-05-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
Product code: JNL Immunochemical, Thyroglobulin Autoantibody
Reason for recall: The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.
FDA root cause: Other
Action: Beckman Coulter sent an "Urgent Product Corrective Action" letter dated June 29, 2010, with attached Customer Response form to the affected customers. The letter identified the affected product and issue. Customers were instructed to: (1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers 916271, 917073, and 918433. (2) Review results in the context of the total clinical presentation of the patient, and rerun questionable results using another reagent. (3) Complete and return a response form within 10 days. (4) For replacement contact Beckman Coulter at (US) 1-800-526-3821, (Canada) 1-800-463-7828. Customer Technical Support can be contacted at 1-800-854- 3633.
Quantity in commerce: 1071 units
Distribution: Worldwide distribution : United States, including states of CA, CO, FL, GA. IA, IL, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and country of Canada.
Product codes and lots: Lot Numbers: 917073, 918433 & 916271

Product code JNL

K062516Class IIAccess Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)Beckman Coulter, Inc. / cleared 2006-10-05

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)