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Terminated

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.

FDA Recall Z-1039-04 · Posted 2004-07-20

Recalling FirmDigene Corp
Recall StatusTerminated
Product CodeLSO
Date Initiated2004-05-28
Date Terminated2004-11-23
Product Quantity206 kits

Reason for Recall

In vitro diagnostic test kit may produce false negative clinical results.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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