FDA-Device2017-07-05Class II
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Beckman Coulter Inc.
Hazard
The Access immunoassays are susceptible to biotin interference.
Sold states
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
Affected count
1,154,084 units total (167,035 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2637-2017Don't want to check this manually?
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