| Class 2 Device Recall Access Thyroglobulin Assay | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MSW
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