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CueSee® Hyperbaric X-High

Eurotrol B.V. · Model 164.002.004 · UDI-DI 08718734961093

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

Description

CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas analyzers.

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.