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Recall Observatory FDA recall evidence

Device product

Access System-Free T4 Assay, B01902E, Catalog No. 33880

Z-2637-2017

May 09, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 77245
Status
Terminated
Classification
Class II
Quantity
1,154,084 units total (167,035 units in US)
Official record key
device-enforcement:Z-2637-2017

Official wording

Reason: The Access immunoassays are susceptible to biotin interference.

Code information: all lots

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Access immunoassays are susceptible to biotin interference.