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U.S. Department of Health and Human Services

Class 2 Device Recall Access Thyroglobulin Antibody II Reagent, Part Number: A32898

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  Class 2 Device Recall Access Thyroglobulin Antibody II Reagent, Part Number: A32898 see related information
Date Initiated by Firm June 29, 2010
Date Posted September 02, 2010
Recall Status1 Terminated 3 on May 04, 2012
Recall Number Z-2355-2010
Recall Event ID 56214
510(K)Number K062516  
Product Classification immunochemical, thyroglobulin autoantibody - Product Code JNL
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.
Code Information Lot Numbers: 917073, 918433 & 916271
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K. ODonovan, Ph.D.
714-961-4483
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = JNL and Original Applicant = BECKMAN COULTER, INC.
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