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CueSee® Hyperbaric

Eurotrol B.V. · Model 1 · UDI-DI 08718734963035

JJS Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
18
Facilities

Description

CueSee® Hyperbaric is an unassayed quality control material intended to verify the precision of pO2 measurements on blood gas analyzers at the upper limit of the measuring range. For laboratory and near patient (point-of-care) testing by healthcare professionals.

Recalls

DateFirmReason
2017-09-07Radiometer America IncRadiometer 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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Data 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.