MHRA medical device alert – Alere HIV Combo (Alere Ltd)

MHRA medical device alert – Alere HIV Combo (Alere Ltd)

October 3, 2017

MDA number: MDA/2017/033

Date issued: 3rd October 2017

The Medicines and Health products Regulatory Agency (MHRA) has issued a medical device alert for:

Alere HIV Combo (Alere Ltd)

Specific devices have been identified through internal investigations to give false positive results.

Actions to be completed:

  • identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN);
  • where affected devices have been used, ensure that initially reactive p24 antigen and/or antibody results that were obtained from EDTA whole blood samples are retested using another method;
  • ensure the results are evaluated in consideration of the overall clinical evaluation before a diagnosis is made; and
  • ensure all relevant members of staff receive the manufacturer’s FSN. and that they understand the problem and to check that the actions have been taken.

Deadlines for actions:

  • Actions underway: 17 October 2017
  • Actions complete: 14 November 2017

To view the alert please visit the website.

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