Device product
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Z-1833-2017
Product summary
- Event
- Event 76838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 889 kits total (6 kits in US)
- Official record key
device-enforcement:Z-1833-2017
Official wording
Reason: Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Code information: Lot No. 671094
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.
Derived failure modes
-
Unknown
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.