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CAPILLARYS CDT MAXI KIT

SEBIA · Model 2029 · UDI-DI 03607360020296

NAO Prescription
3
510(k) clearances
0
Adverse events
2
Recalls
3
Facilities

Description

CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT

Recalls

DateFirmReason
2020-03-02CSL Behring GmbHNegative 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
2018-05-31CSL Behring GmbHSiemens 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.