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Hemoglobin Control Solution

Urit Medical Electronic Co., Ltd. · Model HQ 03,2 bottles /box (Level 1:1mL /bottle,Level 2:1mL /bottle) · UDI-DI 06935740751513

GGM
10
510(k) clearances
2
Adverse events
2
Recalls
18
Facilities

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.