Recall Z-1833-2017 ยท JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Beckman Coulter Inc.
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
| Date | Apr 17, 2017 (initiated Mar 10, 2017) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration. |
| Root cause | Other |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated March 10, 2017, to inform them that Beckman Coulter has determined through customer feedback that a portion of the Access Ferritin Calibrators kit lot listed above contains a calibration card with an incorrect S5 calibrator concentration. The S5 concentration value printed on the card and encoded in the barcode is 1.500 (ng/mL) rather than the correct concentration of 1500 (ng/mL). Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Cu |
| Quantity | 889 kits total (6 kits in US) |
| Distribution | 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 |
| FDA record | Open on fda.gov |