N Latex CDT Kit — Class II medical device recall Z-2931-2018
Terminated recall by CSL Behring GmbH, reported 2018-09-05, distributed in DE, IN, KS, MO, VA. Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) m
| Recall number | Z-2931-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CSL Behring GmbH, Marburg, N/A, Germany |
| Recall initiated | 2018-05-31 |
| Classified | 2018-08-25 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2021-02-12 |
| Distributed | DE, IN, KS, MO, VA |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CZ, DE, ES, FI, FR, GB, HU, IN, IT, JP, LT, LV, NL, NO, PL, PT, SA, SE, SI, SK, TR, TW, UY, ZA |
| Quantity | 6,635 units |
| UPC / GTIN / UDI-DI | 00842768018534 |
| Lot numbers | 47169, 47596, 47716, 48084, 48168 |
| Expiration dates | 2018-06-15, 2018-11-30, 2019-03-21 |
Product
N Latex CDT Kit
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2931-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.