Siemens N Latex CDT Kit- IVD quantitative determination of… — Class II medical device recall Z-1790-2020
Terminated recall by CSL Behring GmbH, reported 2020-04-29, distributed in IN, KS, MO, OH, VA. Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, o
| Recall number | Z-1790-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CSL Behring GmbH, Marburg, N/A, Germany |
| Recall initiated | 2020-03-02 |
| Classified | 2020-04-23 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2020-10-05 |
| Distributed | IN, KS, MO, OH, VA |
| Countries outside the US | AT, AU, BD, BE, CA, CH, CN, CZ, DE, EG, ES, FI, FR, GB, HU, IN, IT, JP, KR, MX, NL, NO, PL, PT, RU, SE, SI, SK, TW, ZA |
| UPC / GTIN / UDI-DI | 00842768018534 |
| Lot numbers | 49729, 49822, 49849, 49985, 50084 |
| Expiration dates | 2020-04-11 |
Product
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Reason for recall
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
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-1790-2020. 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.