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 4 Corrective actions for tests, reagents, controls, calibrators, and culture media for infection testing (n = 38).

Type of corrective action	All n (%)	Subset with FSCA n (%)
Number of cases	38 (100)	32 (100)
No corrective actions	5 (13.2)	0 (16.7)
Corrective actions¹	33 (86.8)	32 (83.3)
Product recall/batch recall	23	23
Cessation of marketing	2	2
Change of design	7	6
Modification of production and/or quality management	22	22
Customer information²	32	32
Modification of the instruction for use	5	4
Software-update	4	4
Modification of labelling	2	2
Modification of raw material	4	3
Customer education³	0	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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