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RAPIDQC® Plus Level 1
Siemens Healthcare Diagnostics Inc. · Model 10323692 · UDI-DI 00630414118383
1
510(k) clearances
3
Adverse events
1
Recalls
18
Facilities
Description
For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-07 | Radiometer America Inc | Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a r |
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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.