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Table 5 Quality of FSN in cases of FSCA related to tests, reagents, controls, calibrators, and culture media for infection testing (n = 32).

From: 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

 

Received n

Missing n

Sufficient n

Insufficient n

German version of the FSN

    

Description of the product failure

31

11

29

2

Description of the required measures

31

11

29

2

Confirmation form part of customer information

24

81

24

0

English version of the FSN

    

Description of the product failure

26

61

25

1

Description of the required measures

26

61

25

1

Confirmation form part of customer information

18

141

18

0

  1. 1in 1 case information of customers by means of a phone call.