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. 2011 May 15;1(1):e000155. doi: 10.1136/bmjopen-2011-000155

Table 3.

Assessment of the relative degree of health hazard by Food and Drug Administration (FDA) classification of recalls for medical-device alerts

Reviewer FDA recall Class I FDA recall Class II FDA recall Class III Uncertain
Reviewer 1 177 (39.6) 205 (45.9) 32 (7.2) 33 (7.4)
Reviewer 2 189 (42.3) 169 (37.8) 66 (14.8) 23 (5.1)
Agreed total* 197 (44.1) 168 (37.6) 54 (12.1) 28 (6.3)
*

κ for overall agreement 0.6.