Z-1039-04

Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents...

Name: Z-1039-04 Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents...
Creator: Digene Corp
Published: 2004-05-28
License: https://open.fda.gov/license/

Qiagen / initiated 2004-05-28 / Terminated

FDA source

Digene Corp began a recall of 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 on 2004-05-28. The reason FDA records is "In vitro diagnostic test kit may produce false negative clinical results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1039-04
Status: Terminated
Initiated: 2004-05-28
Posted: 2004-07-20
Terminated: 2004-11-23
Recalling firm: Qiagen
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.
Product code: LSO Dna-Reagents, Cytomegalovirus
Reason for recall: In vitro diagnostic test kit may produce false negative clinical results.
FDA 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 in commerce: 206 kits
Distribution: Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.
Product codes and lots: Lot number 6234, EXP 10/20/04

Product code LSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)