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N Latex CDT Kit
Siemens Healthcare Diagnostics Products GmbH · Model 10445997 · UDI-DI 00842768018534
1
510(k) clearances
0
Adverse events
2
Recalls
3
Facilities
Description
Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-02 | CSL Behring GmbH | 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 |
| 2018-05-31 | CSL Behring GmbH | Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to t |
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