FDA Medical Device Recalls (openFDA)
CSL Behring GmbH: Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
- Recall number
- Z-1790-2020
- Recalling firm
- CSL Behring GmbH
- Product
- Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
- Status
- Terminated
- Initiated
- 2020-03-02
- Posted
- not on file
- Terminated
- 2020-10-05
- 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
- Root cause
- Under Investigation by firm
- Action
- Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-20-002.A.US to the 5 affected customers in the U.S. on March 5, 2020 via FedEx overnight delivery. ( Urgent Field Corrective Action (UFCA) PP20-002.A.OUS was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities). Letter states reason for recall, health risk, and action to take by the Customer Please review this letter with your Medical Director. Discontinue use of and discard the kit lots listed in Table 1. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
- Quantity
- 297 PCK US; 1247 PCK OUS
- 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
- Lot, serial or model codes
- US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729, 49849, 49985, 50084 Exp. Date: 2020-04-11
- 510(k) numbers
- ["K060677"]
- PMA numbers
- not on file
- Product code
- NAO
- Firm FEI
- 3003098680
- Firm city
- Marburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28