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.
FDA Recall Z-2355-2010 · Posted 2010-09-02
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJNL
Date Initiated2010-06-29
Date Terminated2012-05-04
Product Quantity1071 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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