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RAPIDEC® CARBA NP

BIOMERIEUX SA · Model RAPIDEC® CARBA NP · UDI-DI 03573026464370

PTJ Prescription
1
510(k) clearances
14
Adverse events
1
Recalls
5
Facilities

Description

RAPIDEC® CARBA NP is a phenotypic test for rapid detection and confirmation of carbapenemase enzyme presence in Enterobacteriaceae and Pseudomonas aeruginosa isolated colonies

Recalls

DateFirmReason
2017-05-16Biomerieux IncThe investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK 2 AST-GN colistin (cs01n) compared to agar dilution (the r

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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.