Recalls / —

—#155545

Product

Access Thyroglobulin, A34085G, Catalog No. 33860

FDA product code

MSW — System, Test, Thyroglobulin

Device class

Class 2

Medical specialty

Immunology

510(k) numbers

K002905, K031269

Affected lot / code info

all lots

Why it was recalled

The Access immunoassays are susceptible to biotin interference.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc.

Address

250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated

2017-05-09

Terminated

2018-03-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #155545. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.