Product failure | 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 product failure | 0 (0.0) | 1 (2.8) | 0 (0.0) | 1 (1.8) |
User error | 1 (11.1) | 4 (11.1) | 1 (10.0) | 6 (10.9) |
Root cause not identified | 0 (0.0) | 2 (5.6) | 0 (0.0) | 2 (3.6) |
Product failure identified | 8 (88.9) | 29 (80.6) | 9 (90.0) | 46 (83.6) |
   Material defect | 0 | 0 | 0 | 0 |
   Software error | 8 | 19 | 4 | 31 |
   Calibration error | 0 | 0 | 0 | 0 |
   Electrical error | 0 | 0 | 0 | 0 |
   Mechanical error | 0 | 2 | 0 | 2 |
   Miss of specification | 0 | 1 | 0 | 1 |
   Production error | 0 | 1 | 1 | 2 |
   Incorrect instructions for use | 0 | 0 | 1 | 1 |
   Non-microbial contamination | 0 | 0 | 0 | 0 |
   Packaging error | 0 | 0 | 0 | 0 |
   Microbial contamination | 0 | 0 | 0 | 0 |
   Interference by other substances | 0 | 0 | 0 | 0 |
   Constructional fault | 0 | 6 | 2 | 8 |
   Labeling error | 0 | 0 | 1 | 1 |