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iCa++ Quick™ Sampler
Siemens Healthcare Diagnostics Inc. · Model 11537817 · UDI-DI 00630414609515
JFP
Prescription
1
510(k) clearances
108
Adverse events
5
Recalls
33
Facilities
Description
The iCa++ Quick™ Sampler is designed for in vitro diagnostic use with lithium heparin tubes, for the measurement of ionized Calcium(iCa++) on RAPIDPoint 500 systems and RAPIDLab 1260/1265 systems. This is suitable for professional use in a point-of-careor central laboratory environment.
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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Get your free API keyRead the docsData 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.