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Recall Observatory FDA recall evidence

Device product

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

Z-1790-2020

March 02, 2020

Class II

Product summary

Firm
CSL Behring GmbH
Event
Event 85282
Status
Terminated
Classification
Class II
Quantity
297 PCK US; 1247 PCK OUS
Official record key
device-enforcement:Z-1790-2020

Official wording

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

Code information: US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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