Digene Corp Recalls
Showing 1-2 of 2 recalls
Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.
In vitro diagnostic test kit may produce false negative clinical results.
The recalling firm notified consignees by phone 5/28/04 and by faxed letter 6/2/04. The letter advised of possible false negative test results and that such results should be retested immediately with replacement kits provided by the firm. The notification further advised that positive results should be considered valid if the assay meets all verification and calibration criteria. Consignees were requested to return product and response form.
Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
In Vitro diagnostic test kit may produce false positive patient results
The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.