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Half yearly performance report - January to June 2015

16 December 2015

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9. Recalls

9.1 Medicine recalls

Table 51: Medicine recalls by reason for recall
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Adverse reactions 1 0 2
Foreign matter 0 3 3
Illegal supply 0 0 0
Impurity and degradation 3 3 4
Labelling and packaging 5 8 5
Micro-organisms 0 0 2
pH 0 0 2
Potency 1 1 1
Sterility 1 1 1
Othera 9 6 3
Total 20 22 23
  1. 'Other' includes dissolution, physical defects, observed differences, variable content, diagnostic inaccuracy and wrong product.

9.2 Medical device recalls

Table 52: Medical device (including IVDs) recalls by reason for recall
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Adverse incidents 0 1 3
Diagnostic inaccuracy 29 38 33
Electrical defect 17 25 16
Illegal supply 0 0 1
Labelling and packaging 61 43 56
Mechanical and physical defects 100 96 97
Software defects 69 59 55
Sterility 2 5 4
Othera 9 24 21
Total 287 291 286
  1. Other includes bioavailability, disintegration/dissolution, microbial contamination, variable content, foreign matter, impurity, wrong product, therapeutic inefficiency and observed differences.

9.3 Biologicals recalls

Table 53: Biologicals recalls
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Recalls to hospital level 2 0 0

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