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Hemoglobin M

FDA product code JPB · Class 2 · Hematology

0
Registered devices
0
Adverse events
2
Recalls
0
510(k) clearances

Recent recalls

DateFirmReason
2017-02-24Helena Laboratories, Inc.Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times
2016-04-20Helena Laboratories, Inc.Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.