| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00452-1 |
| Product Name/Description |
N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).
Catalogue Number: OPCS035
Siemens Material Number: 10445996
Lot Numbers: 45834 & 45987 (Expiry 3 Jun 2017); 46116, 46244, 46388 & 46568 (Expiry 10 Oct 2017)
ARTG Number: 178153 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has observed lower values for carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to former lots. CDT results in absolute concentrations are influenced by the patient’s total 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 lower CDT result leads to calculated %CDT values that show a negative bias of approximately 10 to 15% compared to former lots. This could result in a shift of weak positive patient samples into the reference range of 1.19 – 2.47 %CDT which was derived from a study population of healthy adults. It is not expected that samples from patients with chronic heavy alcohol consumption will be misclassified. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising users to discontinue use of and discard the affected lots. Replacement stock will be provided by Siemens. It is recommended that users review the customer letter with the laboratory Medical Director.
This action has been closed out on 18/01/2021 |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |