Type of corrective action | Product based on cultural or biochemical methods1 | Product based on immunological methods2 | Product based on molecular biological methods3 | Total number of products |
---|---|---|---|---|
 | n (%) | n (%) | n (%) | n (%) |
Number of cases | 9 (100.0) | 36 (100.0) | 10 (100.0) | 55 (100.0) |
No corrective actions | 0 (0.0) | 6 (16.7) | 0 (0.0) | 6 (10.9) |
Corrective actions4 | 9 (100.0) | 30 (83.3) | 10 (100.0) | 49 (89.1) |
   Product recall/batch recall | 7 | 25 | 8 | 40 |
   Cessation of marketing | 0 | 0 | 0 | 0 |
   Change of design | 0 | 7 | 2 | 9 |
   Modification of production and/or quality management | 0 | 7 | 2 | 9 |
   Customer information5 | 9 | 29 | 10 | 48 |
   Modification of the instruction for use | 1 | 4 | 1 | 6 |
   Software-update | 8 | 18 | 4 | 30 |
   Modification of labeling | 0 | 2 | 2 | 4 |
   Modification of raw material | 1 | 2 | 0 | 3 |
   Customer education6 | 0 | 0 | 1 | 1 |