Table 3 Product failures of tests, reagents, controls, calibrators and culture media for infection testing (n = 38).
Product failure | All n (%) | Subset with FSCA n (%) |
|---|---|---|
Number of cases | 38 (100) | 32 (100) |
No product failure | 2 (5.3) | 0 (0) |
User error | 0 (0) | 0 (0) |
Root cause not identified | 2 (5.3) | 2 (6.3) |
Product failure identified | 34 (89.5) | 30 (93.7) |
   Material defect | 6 | 5 |
   Software error | 1 | 1 |
   Calibration error | 2 | 2 |
   Electrical error | 0 | 0 |
   Mechanical error | 0 | 0 |
   Miss of specification | 6 | 5 |
   Manufacturing error | 8 | 7 |
   Incorrect instructions for use | 2 | 2 |
   Non-microbial contamination | 0 | 0 |
   Packaging error | 1 | 1 |
   Microbial contamination | 3 | 3 |
   Interference by other substances | 1 | 0 |
   Constructional fault | 0 | 0 |
   Labelling error | 4 | 4 |