Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for perfor
FDA device recall Z-1039-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Digene Corp
- Reason for recall
- In vitro diagnostic test kit may produce false negative clinical results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LSO
- Quantity affected
- 206 kits
- Distribution
- Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.
- Date initiated
- 2004-05-28
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-23
- Location
- Gaithersburg, MD
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