Z-0776-06

Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001

Name: Z-0776-06 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001
Creator: Roche Diagnostics Corp.
Published: 2006-04-04
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-04-04 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001 on 2006-04-04. The reason FDA records is "The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0776-06
Status: Terminated
Initiated: 2006-04-04
Posted: 2006-04-19
Terminated: 2006-07-03
Recalling firm: Roche Diagnostics GmbH
Product: Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001.
Product code: NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Reason for recall: The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.
FDA root cause: Other
Action: Consignees were notified by letter dated 4/4/06 to notify customers of the problem and provide a work-around.
Quantity in commerce: unknown.
Distribution: Nationwide.
Product codes and lots: All lots.

Product code NPQ

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)