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RAPIDSystems™ AutomaticQC Cartridge
Siemens Healthcare Diagnostics Inc. · Model 10310323 · UDI-DI 00630414465883
1
510(k) clearances
5
Adverse events
1
Recalls
21
Facilities
Description
For in vitro diagnostic use for multi-level quality control of RAPIDPoint 400/500 series and RAPIDLab 1200 series systems.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-05-24 | Radiometer America Inc | The 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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