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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 II

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
GKZ	Counter, Differential Cell	2	4	1
LCO	Platelet Factor 4 Radioimmunoassay	2	0	4
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	2	1	2
GFO	Activated Partial Thromboplastin	2	1	2
JPA	System, Multipurpose For In Vitro Coagulation Studies	2	2	1
POV	Semen Analysis Device	2	1	2
GGN	Plasma, Coagulation Control	2	0	2
GGP	Test, Qualitative And Quantitative Factor Deficiency	2	0	2
JBP	Activated Whole Blood Clotting Time	2	0	2
KHE	Reagent, Occult Blood	2	0	2
OYE	Flow Cytometric Reagents And Accessories.	2	1	1
GGW	Test, Time, Partial Thromboplastin	2	1	0
JOY	Device, Automated Cell-Locating	2	0	1
JOZ	System, Automated Platelet Aggregation	2	0	1
JWO	Device, Blood Volume Measuring	2	1	0
KFF	Assay, Heparin	2	1	0
LCP	Assay, Glycosylated Hemoglobin	2	0	1
NOT	Microscope, Automated, Image Analysis, Operator Intervention	2	1	0
NRF	Material, Quality Control, Semen Analysis	2	0	1
OQX	Self-Contained Blood Grouping	2	0	1