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ChloroChek® Chloridometer® Sweat Chloride Analyzer
ELITECHGROUP INC. · Model Model 3400 · UDI-DI 03661540304088
1
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities
Description
The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-09-02 | Siemens Healthcare Diagnostics Inc | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge |
| 2016-09-02 | Siemens Healthcare Diagnostics Inc | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge |
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