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U.S. Department of Health and Human Services

Class 2 Device Recall Access Thyroglobulin Assay

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  Class 2 Device Recall Access Thyroglobulin Assay see related information
Date Initiated by Firm July 28, 2015
Date Posted September 03, 2015
Recall Status1 Terminated 3 on April 13, 2016
Recall Number Z-2733-2015
Recall Event ID 71878
510(K)Number K002905  K031269  
Product Classification System,test,thyroglobulin - Product Code MSW
Product Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
Code Information Catalogue number: 33860 Lot numbers: 431990 434727 430969 522896 523251  Expiration date: 10/31/16 12/31/16 08/31/16 04/30/17 05/31/17
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 07/28/2015 the firm sent out customer notification letters via first class mail and e-mail. The firm's letter contained the following instructions: 1. Discard all Access Thyroglobulin reagent pack lots listed in the letter. 2. Evaluate Access Thyroglobulin results <10 ng/mL when using the reagent pack lot numbers listed to determine if controls and/or patients were higher than expected or did not match the clinical status of the patient. 3. At the discretion of the Laboratory Director, notify clinicians that it is possible the Access Thyroglobulin sample results reported by the laboratory were affected by this issue. The firm's notification letter requests that the information be shared with laboratory staff. If any affected products have been forwarded provide a copy of the letter to them. The firm requests that customers complete and return the Response Form within 10 days. Any questions contact the Customer Care Center: 1. From website at http://www.beckmancoulter.com 2. By phone: call 1-800-854-3633 in the United States and Canada. 3. Outside the United States and Canada, contact local Beckman Coulter representative
Quantity in Commerce 3,035 (U.S.) and 7,123 (International)
Distribution Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, Morocco, New Zealand, Oman, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam and Yemen.
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 = MSW and Original Applicant = BECKMAN COULTER, INC.
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