Z-0956-2007

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

Name: Z-0956-2007 MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001
Creator: Roche Diagnostics Corp.
Published: 2007-05-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-05-14 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corp. began a recall of MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001 on 2007-05-14. The reason FDA records is "False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0956-2007
Status: Terminated
Initiated: 2007-05-14
Posted: 2007-06-22
Terminated: 2009-12-17
Recalling firm: Roche Diagnostics GmbH
Product: MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
Product code: NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Reason for recall: False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were sent an Urgen Medical Device Correction letter dated 5/14/07 which instructs them to define and establish a lower detection limit, to use UNG to prevent carryover whenever possible, and to confirm low positive results through an independent experiment. A revised device correction letter dated 6/15/07 was subsequently sent to each consignee updating the reason for recall and associated risks.
Quantity in commerce: 4,201
Distribution: Nationwide.
Product codes and lots: Lots 11962700, exp. 8/31/07; 12030400, exp. 6/30/07; 12071100, exp. 9/30/07; 12125800, exp. 10/31/07; 12214300, exp. 12/31/07; 12360200, exp. 3/31/08; 12426200, exp. 4/3008; 12543600, exp. 5/31/08; 12672500, exp. 5/31/08; 12725300, exp. 6/30/08; 12799800, exp. 7/31/08; 12917900, exp. 8/31/08; 13024000, exp. 9/30/08; 13081700, exp. 9/30/08; 13197600, exp. 12/31/08 and 13266600, exp. 2/28/09.

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)