Z-2637-2017 Class II Terminated
FDA device recall Z-2637-2017 was initiated by Beckman Coulter Inc. on May 9, 2017 and is designated Class II. Reason for recall: The Access immunoassays are susceptible to biotin interference. The recall status is terminated (terminated March 30, 2018). Affected quantity: 1,154,084 units total (167,035 units in US).
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
- 1,154,084 units total (167,035 units in US)
Product Description
Reason for Recall
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