Class II — CSL Behring GmbH
| Recalling firm | CSL Behring LLC |
|---|---|
| Registered facility | CSL Behring LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997 |
| Quantity | 297 PCK US; 1247 PCK OUS |
| Distribution | IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Taiwan |
| Initiated | 2020-03-02 |
| Classified | 2020-04-23 |
| Terminated | 2020-10-05 |
| Recall number | Z-1790-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CSL Behring GmbH (Z-1790-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85282/
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