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Table 8 Quality of FSN in cases of FSCA related to analysers and general consumables 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

Culture based analysers and general consumables - German version of the FSN

    

Description of the product failure

13

0

13

0

Description of the required measures

13

0

13

0

Confirmation form part of customer information

11

2

11

0

Culture based analysers and general consumables - English version of the FSN

    

Description of the product failure

13

0

13

0

Description of the required measures

13

0

13

0

Confirmation form part of customer information

9

4

9

0

Molecular biological analysers and general consumables - German version of the FSN

    

Description of the product failure

7

0

6

1

Description of the required measures

7

0

6

1

Confirmation form part of customer information

5

2

5

0

Molecular biological analysers and general consumables - English version of the FSN

    

Description of the product failure

6

1

5

1

Description of the required measures

6

1

5

1

Confirmation form part of customer information

2

5

2

0