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HemaPrep

Cellavision AB · Model XU-10012-01 · UDI-DI 07350040976753

GKJ Prescription
6
510(k) clearances
105
Adverse events
1
Recalls
4
Facilities

Description

Semi-Automated Blood Smearing Device

Recalls

DateFirmReason
2005-12-15Beckman Coulter IncThere is a risk of sample misidentification when processing samples in the Manual aspiration mode.

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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.