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RAPIDPoint® 500e Blood Gas System
Siemens Healthcare Diagnostics Inc. · Model 11416751 · UDI-DI 00630414286143
1
510(k) clearances
105
Adverse events
5
Recalls
33
Facilities
Description
The RAPIDPoint® 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and issuitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases,electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-06 | Roche Diagnostics Operations, Inc. | May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to |
| 2011-04-07 | Radiometer America Inc | Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon install |
| 2008-09-05 | Radiometer America Inc | The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the so |
| 2005-09-29 | Radiometer America Inc | Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently prov |
| 2005-09-29 | Radiometer America Inc | Under certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provid |
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