Recall Z-1790-2020— CSL Behring GmbH
Class II · Terminated
Class II FDA medical device recall by CSL Behring GmbH, initiated 2020-03-02, terminated 2020-10-05. It names one FDA 510(k) clearance: K060677. Product: Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997. 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.
- Recalling firm
- CSL Behring GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-02
- Terminated
- 2020-10-05
- Firm location
- Marburg, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.