# FDA recall Z-1790-2020

> **CSL Behring GmbH** · Class II · device recall initiated 2020-03-02.

## 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

## 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

## Key facts

- **Recall number:** Z-1790-2020
- **Recalling firm:** CSL Behring GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-02
- **Report date:** 2020-04-29
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marburg, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1790-2020

## Citation

> AI Analytics. FDA recall Z-1790-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1790-2020. Source: US FDA. Licensed CC0.

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