Z-1833-2017 Class II Terminated
FDA device recall Z-1833-2017 was initiated by Beckman Coulter Inc. on March 10, 2017 and is designated Class II. Reason for recall: Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration. The recall status is terminated (terminated June 27, 2017). Affected quantity: 889 kits total (6 kits in US).
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- March 10, 2017
- Termination Date
- June 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 889 kits total (6 kits in US)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Zimbabwe.