CSL Behring GmbH: Medical Device Recall in 2020 - (Recall #: Z-1790-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 2, 2020

Date Posted: April 29, 2020

Recall Number: Z-1790-2020

Event ID: 85282

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

Status: Terminated

Product Quantity: 297 PCK US; 1247 PCK OUS

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

Voluntary or Mandated:

Voluntary: Firm initiated