Z-1001-03

MagNA Pure LC Instrument; Catalog number 2236931

Name: Z-1001-03 MagNA Pure LC Instrument; Catalog number 2236931
Creator: Roche Diagnostics Corp.
Published: 2003-05-27
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-05-27 / Terminated / root cause: software

FDA source

Roche Diagnostics Corp. began a recall of MagNA Pure LC Instrument; Catalog number 2236931 on 2003-05-27. The reason FDA records is "Potential for false negative patient results with software version 3.0". 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-1001-03
Status: Terminated
Initiated: 2003-05-27
Posted: 2003-07-15
Terminated: 2003-11-18
Recalling firm: Roche Diagnostics GmbH
Product: MagNA Pure LC Instrument; Catalog number 2236931.
Reason for recall: Potential for false negative patient results with software version 3.0
Root cause tag: software
FDA root cause: Other
Action: An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
Quantity in commerce: 17
Distribution: California, Georgia, Illinois, Maine, Michigan, Mississippi, New York Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
Product codes and lots: All units with software version 3.0.

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)