Device recall: Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep…

Class II FDA enforcement event 63312. Recall start date: 16 Jul 2012. Status in the FDA record: Terminated. Termination date: 22 Jul 2015.

Reason for recall, in the words of FDA

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Roche Molecular Systems, Inc. started this device recall on 16 Jul 2012. The firm address in the FDA record is in Branchburg, NJ. FDA put the recall in Class II. FDA event 63312 has 10 product records. The first FDA enforcement report date is 19 Dec 2012. The record gives the status Terminated, with the termination date 22 Jul 2015.

FDA enforcement report The 10 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution

Recalling firm

Roche Molecular Systems, Inc., Branchburg, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

10 product records in the event.

FDA event 63312: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0484-2013	Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain…	884 units	Class II	Terminated	19 Dec 2012
Z-0485-2013	The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.	816 units	Class II	Terminated	19 Dec 2012
Z-0486-2013	The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.	13 units	Class II	Terminated	19 Dec 2012
Z-0487-2013	LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.	3,772 units	Class II	Terminated	19 Dec 2012
Z-0488-2013	LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.	1,213 units	Class II	Terminated	19 Dec 2012
Z-0489-2013	The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.	77 units	Class II	Terminated	19 Dec 2012
Z-0490-2013	The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.	855 units.	Class II	Terminated	19 Dec 2012
Z-0491-2013	DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.	1,015 units	Class II	Terminated	19 Dec 2012
Z-0492-2013	DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.	479 units	Class II	Terminated	19 Dec 2012
Z-0493-2013	DataCare POC – is an information management system that provides data management functionality for managing point-of -care testing data.	126 units	Class II	Terminated	19 Dec 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 10Median of the firm: 1
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of Roche Molecular Systems, Inc.
Initiated	Product (first record)	Type	Class	Records
21 Dec 2022	cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190	Device	Class II	3
8 Sep 2022	cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid T	Device	Class II	1
16 Nov 2021	cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190	Device	Class II	1
3 Sep 2021	cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190	Device	Class II	1
4 Aug 2021	cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190	Device	Class II	1
25 Mar 2021	cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Li	Device	Class II	2
23 Nov 2020	uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001	Device	Class II	1
19 Nov 2020	The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection	Device	Class II	1
3 Jun 2020	MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is in	Device	Class II	1
2 May 2018	MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample ext	Device	Class II	1

Roche Molecular Systems, Inc.: all 30 events

Official channels

FDA enforcement report Z-0484-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 63312. https://recallregister.com/fda/ii/63312/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution
What quantity of product is in FDA event 63312?: The event has 10 product records. The first record gives this quantity: 884 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.