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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Digene Corp
Lot Codes / Batch Numbers
Lot number 6234, EXP 10/20/04
Products Sold
Lot number 6234, EXP 10/20/04
Digene Corp is recalling Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test due to In vitro diagnostic test kit may produce false negative clinical results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In vitro diagnostic test kit may produce false negative clinical results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026