Recall Z-2931-2018 ยท NAO Test, Carbohydrate Deficient Transferrin
CSL Behring GmbH
N Latex CDT Kit
| Date | May 31, 2018 |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may be influenced by patients transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT. As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This cou |
| Root cause | Under Investigation by firm |
| Action | On May 31, 2018 Siemens Healthcare Diagnostics issued Urgent Medical Device Correction notices (UMDC) PP18-002.A.US to the 4 affected customers in the U.S. Actions to be Taken by the Customer are as follows: Siemens Healthcare Diagnostics has assigned optimized values to the affected lots of standards and controls included in the kit lots. Those lots of standards and controls can be used with the revised assigned values and acceptance ranges. As per Urgent Medical Device Correction (UMDC) PP18-001.A.US, customers were instructed to: - Recalibrate your CDT method with N CDT Standard lots li |
| Quantity | 6635 units |
| Distribution | Domestic - DE, IN, KS, MO & VA Internationally - Australia Austria Belgium Canada China Czech Republic Finland France Germany Hungary India Italy Japan Latvia Lithuania Netherlands Norway Poland Portugal Saudi Arabia Slovakia Slovenia South Africa South Koria Spain Sweden Switzerland Taiwan Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060677 | N LATEX CDT Dade Behring, Inc., Aug 25, 2006 |