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Miris Check™

Miris AB · Model 39-01-003 · UDI-DI 07350107530027

QEI
1
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities

Description

Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionized water and mix. Warm to 35-40° C before use.

Recalls

DateFirmReason
2022-03-16Stanbio Laboratory, LPThe device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous re

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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.