Safety of laboratory analyzers for infection testing - results of the market surveillance by the BfArM until end 2007

Table 8 Corrective actions for consumables of analyzers for diagnostics of infective diseases since begin 1999 until end of 2007 (multiple entries).

Type of corrective action	Product based on cultural or biochemical methods¹	Product based on immunological methods²	Product based on molecular biological methods³	Total number of products
	n (%)	n (%)	n (%)	n (%)
Number of cases	8 (100.0)	6 (100.0)	4 (100.0)	18 (100.0)
No corrective actions	0 (0.0)	1 (16.7)	0 (0.0)	1 (5.6)
Corrective actions⁴	8 (100.0)	5 (83.3)	4 (100.0)	17 (94.4)
Product recall/batch recall	5	3	4	12
Cessation of marketing	0	0	1	1
Change of design	0	0	0	0
Modification of production and/or quality management	4	5	2	11
Customer information⁵	7	5	4	16
Modification of the instruction for use	2	1	1	4
Software-update Modification of	1	0	0	1
labeling Modification of raw	1	0	0	1
material	0	1	1	2
Customer education⁶	1	0	0	1

¹e.g., culture, strain differentiation, susceptibility testing; ²e.g., immunological typing of strains, serology, ELISA, Western blot; ³e.g., PCR, hybridisation assay; ⁴multiple entries for the different subgroups of corrective actions were allowed; ⁵alone or in combination with a recall (in case of a recall customer information is mandatory); ⁶education of a single customer e.g., after a user error was not defined to be a customer education.

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