FDA Device recall Z-2931-2018
N Latex CDT Kit
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of N Latex CDT Kit by Csl Behring, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2931-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-31 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Csl Behring |
| Distribution | DE, IN, KS, MO, VA |
Product
N Latex CDT Kit
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 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. There are no control or calibrator materials that would catch this bias.
Identifiers
| code_info | UDI - 842768018534 Lot # 47169, Exp Date: 2018-06-15 Lot # 47596, Exp Date: 2018-11-30 Lot # 47716, Exp Date: 201…UDI - 842768018534 Lot # 47169, Exp Date: 2018-06-15 Lot # 47596, Exp Date: 2018-11-30 Lot # 47716, Exp Date: 2018-11-30 Lot # 48084, Exp Date: 2019-03-21 Lot # 48168, Exp Date: 2019-03-21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2931-2018%22
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