Z-1833-2017 Class II Terminated
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
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Reason for Recall
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
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.
Code Information
Lot No. 671094