Z-1790-2020 Class II Terminated
FDA device recall Z-1790-2020 was initiated by CSL Behring GmbH on Mar 2, 2020 and is designated Class II. 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 The recall status is terminated (terminated Oct 5, 2020). Affected quantity: 297 PCK US; 1247 PCK OUS.
Recall details
- Product Type
- Devices
- Report Date
- Apr 29, 2020
- Initiation Date
- Mar 2, 2020
- Termination Date
- Oct 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 297 PCK US; 1247 PCK OUS
Product description
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 pattern
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
Code information
US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1790-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026