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Terminated

Access Thyroglobulin, A34085G, Catalog No. 33860

FDA Recall Z-2636-2017 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeMSW
Date Initiated2017-05-09
Date Terminated2018-03-30
Product Quantity83,504 units total (23,285 units in US)

Reason for Recall

The Access immunoassays are susceptible to biotin interference.

Firm Action

An urgent Medial Device Recall letter dated 5/9/17 was sent to customers to inform them that Beckman Coulter is initiating a field action for Access Total T3, Access Thyroglobulin, Access Free T4, and Access GI Monitor. Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed above are susceptible to biotin interference. During interference testing the interference occurred with samples that contained 100 ng/mL of biotin. This level of biotin is greater than the maximum biotin concentration observed in the normal healthy population. Customers are informed of the impact, action, and resolution. Customers are instructed to respond within 10 days: electronically via email or manually by completing and returning the enclosed response form. Customers with any questions regarding the notice are instructed to contact Customer Technical Support Center: From our website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative.

Root Cause

Device Design

Distribution Pattern

Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Malawi, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, Zambia, Zimbabwe

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031269ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc. · 2003-05-02K002905ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZERBeckman Coulter, Inc. · 2000-10-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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