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CueSee® CO-OX
Eurotrol B.V. · Model S3A · UDI-DI 08718734961024
GGM
Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
CueSee® CO-OX S3A is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-10-18 | EUROTROL INC | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
| 2018-10-18 | EUROTROL INC | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
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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.