Z-1711-2017 Class II Terminated
FDA device recall Z-1711-2017 was initiated by Beckman Coulter Inc. on March 7, 2017 and is designated Class II. Reason for recall: Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the… The recall status is terminated (terminated March 1, 2018). Affected quantity: 851 units total for all products (291 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- March 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 851 units total for all products (291 units in US)
Product Description
Reason for Recall
Distribution Pattern
Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe