Z-0297-05

MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001

Name: Z-0297-05 MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001
Creator: Roche Diagnostics Corp.
Published: 2004-11-05
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-11-05 / Terminated / root cause: software

FDA source

Roche Diagnostics Corp. began a recall of MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001 on 2004-11-05. The reason FDA records is "Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0297-05
Status: Terminated
Initiated: 2004-11-05
Posted: 2004-12-08
Terminated: 2005-08-29
Recalling firm: Roche Diagnostics GmbH
Product: MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
Product code: NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Reason for recall: Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.
Root cause tag: software
FDA root cause: Other
Action: Consignees were notified via letter dated 11/5/04, which provides the user with a workaround.
Quantity in commerce: 65
Distribution: Nationwide.
Product codes and lots: All systems using software version 3.09.

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)