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Hematology devices

267 product codes reviewed by the Hematology panel. 4,199 510(k) clearances and 1,033 recalls in the FDA data, 71% of those recalls name a 510(k).

14510(k)s in 12 months

45recalls in 12 months

737recalls that name a 510(k)

Active product codes, Class I

Code	Device	Class	Recalls, 12 mo
GIO	Tube, Collection, Capillary Blood	1	13
LJX	Test, Urine Leukocyte	1	3
GIF	Diluent, Blood Cell	1	1
JPH	Test, Erythrocyte Sedimentation Rate	1	1
NJT	Immunohistochemistry Reagents And Kits	1	1