Z-1928-2009

AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number...

Name: Z-1928-2009 AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number...
Creator: Roche Molecular Systems, Inc.
Published: 2009-06-02
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2009-06-02 / Terminated / root cause: software

FDA source

Roche Molecular Systems, Inc. began a recall of AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog... on 2009-06-02. The reason FDA records is "Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can...". 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-1928-2009
Status: Terminated
Initiated: 2009-06-02
Posted: 2009-08-27
Terminated: 2010-08-13
Recalling firm: Roche Molecular Systems Inc
Product: AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.
Product code: JJH Clinical Sample Concentrator
Reason for recall: Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction Letters were sent on June 2, 2009 by first class mail. The letter described the issue; impact on results; clinical implications; the workaround; and the actions required, which include following the workaround until a new version of AMPLILINK software is available and filing the letter for future reference. Questions or concerns should be directed to Roche Diagnostics Technical Support at 1-800-526-1247.
Quantity in commerce: 282
Distribution: Nationwide Distribution
Product codes and lots: Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.

Product code JJH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)