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RAPIDPOINT® 340/350 Valve Module

Siemens Healthcare Diagnostics Inc. · Model 10376971 · UDI-DI 00630414566788

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10
510(k) clearances
5
Adverse events
1
Recalls
21
Facilities

Description

to be used on the RAPIDPOINT ® 340/350

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.