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RAPIDPoint® 400 Measurement Cartridge

Siemens Healthcare Diagnostics Inc. · Model 10329756 · UDI-DI 00630414469225

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1
510(k) clearances
5
Adverse events
1
Recalls
21
Facilities

Description

RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.

Recalls

DateFirmReason
2005-05-24Radiometer America IncThe package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the

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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.