Recall Z-1039-04 ยท LSO Dna-Reagents, Cytomegalovirus
Digene Corp
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.
| Date | Jul 20, 2004 (initiated May 28, 2004) |
| Status | Terminated |
| Reason | In vitro diagnostic test kit may produce false negative clinical results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 206 kits |
| Distribution | Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.