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PRODUCT RECALL: Clearview Simplify D-dimer (8 March 2007)

Unipath Ltd is recalling Clearview Simplify D-dimer coagulation test kit, lot numbers PT030A and PT031A (containing 10 devices with batch number 682-024), because a decrease in sensitivity has been identified which could result in false negative results. Recipients are asked to stop using the affected product, quarantine any remaining stock and contact Debbie Petersen (tel 01234 835141) or Nicola Emerton (tel 01234 835148) to arrange product returns and credit. Unipath is recommending that patients who previously tested negative with the affected lots/batch should be considered for follow-up.

Further details are provided in notices from the manufacturer, available from the Medicines and Healthcare products Regulatory Agency

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