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CueSee® CO-OX

Eurotrol B.V. · Model LVB · UDI-DI 08718734961635

GGM Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities

Description

CueSee® CO-OX LVB is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory). CueSee® CO-OX LVB contains: 1 bottle of CueSee® CO-OX S1B (DI: 08718734961550), 1 bottle of CueSee® CO-OX S2B (DI: 08718734961567), 1 bottle of CueSee® CO-OX S3B (DI: 08718734961574), 1 bottle of CueSee® CO-OX S4B (DI: 08718734961581), 1 bottle of CueSee® CO-OX S5B (DI: 08718734961598).

Recalls

DateFirmReason
2018-10-18EUROTROL INCIncorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
2018-10-18EUROTROL INCIncorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

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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.