Z-0934-04

AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190

Name: Z-0934-04 AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190
Creator: Roche Diagnostics Corp.
Published: 2004-03-10
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-03-10 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190 on 2004-03-10. The reason FDA records is "Marketed without PMA or 510(k) approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0934-04
Status: Terminated
Initiated: 2004-03-10
Posted: 2004-07-20
Terminated: 2005-01-07
Recalling firm: Roche Diagnostics GmbH
Product: AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
Reason for recall: Marketed without PMA or 510(k) approval.
FDA root cause: Other
Action: Consignees were notified of the removal by phone on 3/10/04.
Quantity in commerce: 3
Distribution: Florida and Virginia.
Product codes and lots: Lot E12989; exp 7/04.

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)