Z-2074-2017 Class II Terminated
FDA device recall Z-2074-2017 was initiated by Beckman Coulter Inc. on April 13, 2017 and is designated Class II. Reason for recall: Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit… The recall status is terminated (terminated June 4, 2018). Affected quantity: 45,278 units total (2,419 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 13, 2017
- Termination Date
- June 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,278 units total (2,419 units in US)
Product Description
Reason for Recall
Distribution Pattern
Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe