Z-2403-2012Class II

Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS...

Name: Z-2403-2012 Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS...
Creator: Roche Molecular Systems, Inc.
Published: 2012-04-23
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2012-04-23 / Terminated / root cause: design

FDA source

Roche Molecular Systems, Inc. began a recall of Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory... on 2012-04-23. FDA classified it as Class II and gives the reason as "When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2403-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-23
Posted: 2012-09-18
Terminated: 2014-02-12
Recalling firm: Roche Molecular Systems Inc
Product: Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Product code: OYT
Reason for recall: When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
Root cause tag: design
FDA root cause: Device Design
Action: Roche Molecular Systems Inc. sent "Urgent Field Safety Notice" letters and Faxback forms on 4/23/2012 via UPS to all affected customers. The issue was described and recommended actions were provided. A Product Advisory Notice and an Updated Field Safety Notice were issued as well.
Quantity in commerce: 1292 instruments
Distribution: Nationwide (USA) Distribution
Product codes and lots: 05666678001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2403-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2403-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-18

Product code OYT

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)