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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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11. Recalls

11.1. Medicine recalls

Table 65 Medicine recalls by reason for recall
2017-18 2018-19
July to June
Number (% of Total)
Reason for recall
Adverse reactions 1 (3%) 2 (5%)
Foreign matter 5 (14%) 5 (12%)
Illegal supply 2 (6%) 2 (5%)
Impurity and degradation 1 (3%) 4 (10%)
Labelling and packaging 8 (23%) 14 (34%)
Micro-organisms 1 (3%) 2 (5%)
pH 0 0
Potency 3 (8%) 1 (2%)
Sterility 1 (3%) 0
Other[a] 13 (37%) 11 (27%)
Total 35 (100%) 41 (100%)

Footnotes


11.2. Medical device recalls

Table 66 Medical device (including IVDs) recalls by reason for recall
2017-18 2018-19
July to June
Number (% of Total)
Reason for recall
Adverse incidents 3 (0.5%) 5 (0.8%)
Diagnostic inaccuracy 3 (0.5%) 66 (11%)
Electrical defect 41 (7%) 23 (4%)
Illegal supply 2 (0.4%) 1 (0.2%)
Labelling and packaging 14 (2%) 131 (22%)
Mechanical and physical defects 202 (37%) 203 (34%)
Software defects 97 (17%) 130 (22%)
Sterility 5 (1%) 3 (0.5%)
Other[a] 187 (34%) 34 (6%)
Total 554 (100%) 596 (100%)

Footnotes


11.3. Biological recalls

Table 67 Biological recalls
2017-18 2018-19
July to June
Recalls to hospital level 25 29

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