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  1. Recalls (Biologics)

CBER FY 2018 Recall Postings

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

CBER FY 2018 Recall Postings
  Allergenic Blood Blood Deriv. Device IVD Source Plasma Therapeutic Tissue Vaccine Total Events
by Class
Class I               2   2
Class II   305   5   21   15   346
Class III 2 106   9 2 80   2 1 202
Mixed Class (Cl.
I/II)
                   
Mixed Class (Cl.
I/III)
                   3
Mixed Class (Cl.
II/III)
  59       1   3   60
Total Events
by Product
2 470   14 2 102   22 1 613
Direct Recall Classification (DRC) Related Data 2018
Number of AI Requests during FY 18 624
Number of Alerts to Possible Recall sent during FY 18 0
Number of DRC Recalls Classifed during FY 18 599

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