Z-2638-2017 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
May 9, 2017
Termination Date
March 30, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
249,597 units total (9,388 units in US)

Product Description

Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687

Reason for Recall

The Access immunoassays are susceptible to biotin interference.

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

Code Information

all lots