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Hemaprep

J P Gilbert Company Inc · Model 756300 · UDI-DI 00860010522301

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

Description

Blood smear instrument automated; Microscope slide maker IVD; portable, light weight (1 pound); no external power required.

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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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.