Field safety notices released by manufacturers in cases of failure of products for infection testing: analysis of cases reported to the BfArM between 2005 and 2007

Table 7 Corrective actions for analysers and general consumables for infection testing (n = 20).

Type of corrective action	All analysers n (%)	All general consumables n (%)
Number of cases	13 (100)	7 (100)
No corrective actions	0 (0)	0 (0)
Corrective actions¹	13 (100)	7 (100)
Product recall/batch recall	10	6
Cessation of marketing	0	1
Change of design	1	0
Modification of production and/or quality management	1	4
Customer information²	13	7
Modification of the instruction for use	1	3
Software-update	11	1
Modification of labelling	0	0
Modification of raw material	0	1
Customer education³	1	0

¹Multiple entries for the different subgroups of corrective actions were allowed; ²Alone or in combination with a recall (in case of a recall customer information is mandatory); ³Education of a single customer, e.g., after a user error was not defined to be a customer education.

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