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CueSee® Hypoxic

Eurotrol B.V. · Model CueSee® Hypoxic X-Low · UDI-DI 08718734960652

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

Description

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).

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.