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Hb AFSA2 CONTROL (1)

SEBIA · Model 4758 · UDI-DI 03607360047583

JCM Prescription
10
510(k) clearances
2
Adverse events
1
Recalls
5
Facilities

Recalls

DateFirmReason
2016-11-07Tosoh Bioscience, Inc.The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at th

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

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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.