medical Class II Updated 2020-04-29

CSL Behring GmbH recalls Siemens N Latex CDT Kit- IVD quantitative determination of c

Recalled Product

Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

Hazard / Issue

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

Issued by

FDA

Affected States: IN, KS, MO, OH, VA
Lot/Code Info: US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11
View official government recall

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