Z-0655-03

Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only

Name: Z-0655-03 Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only
Creator: Digene Corp
Published: 2003-02-07
License: https://open.fda.gov/license/

Qiagen / initiated 2003-02-07 / Terminated

FDA source

Digene Corp began a recall of Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only on 2003-02-07. The reason FDA records is "In Vitro diagnostic test kit may produce false positive patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0655-03
Status: Terminated
Initiated: 2003-02-07
Posted: 2003-03-19
Terminated: 2003-07-16
Recalling firm: Qiagen
Product: Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.
Product code: MAQ Kit, Dna Detection, Human Papillomavirus
Reason for recall: In Vitro diagnostic test kit may produce false positive patient results
FDA root cause: Other
Action: The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.
Quantity in commerce: 848 kits/ 96 assays per kit
Distribution: Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
Product codes and lots: Lot 2759/ exp 2003-08-31

Product code MAQ

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)